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Rose K, Edalatpour A, Gunderson KA, Michelotti BF, Poore SO, Gast K. Topical Tranexamic Acid (TXA) Decreases Time to Drain Removal, Wound Healing Complications, and Postoperative Blood Loss in Autologous Breast Reconstruction: A Retrospective Study. Plast Surg (Oakv) 2024; 32:395-403. [PMID: 39104927 PMCID: PMC11298145 DOI: 10.1177/22925503221120549] [Citation(s) in RCA: 3] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/11/2022] [Revised: 04/25/2022] [Accepted: 06/12/2022] [Indexed: 08/07/2024] Open
Abstract
Introduction: Drain placement is commonplace after many plastic surgery procedures to evacuate excess blood and fluid. Tranexamic acid (TXA) is an antifibrinolytic that has been shown to decrease bleeding and fluid production at surgical sites and can be administered orally, intravenously, and topically. The purpose of this study is to evaluate the effect of topical TXA on drain removal in abdominally based autologous breast reconstruction (ABABR). Methods: A retrospective chart review was performed on patients who underwent ABABR from August 2018 to November 2019. In 1 cohort, a 2.5% TXA solution was topically applied to the abdominal wall prior to closure. Drains were removed when output was less than 30 mL/day for 2 consecutive days. The primary outcome was days to drain removal. Secondary outcomes include daily inpatient drain output, postoperative hemoglobin levels, blood transfusions, and complications within 30 days postoperatively. Results: Eighty-three patients were included, with 47 in the control group and 36 in the TXA group. Drains were removed significantly earlier in patients who received TXA (16 days vs 23 days, P = .02). Additionally, significantly fewer patients required postoperative blood transfusions in the TXA group (2 vs 14, P = .005). Abdominal complications were fewer in the TXA group with significantly less wound healing complications (22% vs 49%, P = .01). There was no difference in flap loss or systemic thromboembolic events. Conclusion: Topical TXA use in ABABR results in earlier abdominal drain removal, less blood transfusions, and lower abdominal wound complications without an increased risk of flap loss or adverse patient outcomes.
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Affiliation(s)
- Katherine Rose
- Division of Plastic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Armin Edalatpour
- Division of Plastic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Kirsten A. Gunderson
- Division of Plastic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Brett F. Michelotti
- Division of Plastic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Samuel O. Poore
- Division of Plastic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Katherine Gast
- Division of Plastic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
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Gibbs VN, Champaneria R, Sandercock J, Welton NJ, Geneen LJ, Brunskill SJ, Dorée C, Kimber C, Palmer AJ, Estcourt LJ. Pharmacological interventions for the prevention of bleeding in people undergoing elective hip or knee surgery: a systematic review and network meta-analysis. Cochrane Database Syst Rev 2024; 1:CD013295. [PMID: 38226724 PMCID: PMC10790339 DOI: 10.1002/14651858.cd013295.pub2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/17/2024]
Abstract
BACKGROUND Hip and knee replacement surgery is a well-established means of improving quality of life, but is associated with a significant risk of bleeding. One-third of people are estimated to be anaemic before hip or knee replacement surgery; coupled with the blood lost during surgery, up to 90% of individuals are anaemic postoperatively. As a result, people undergoing orthopaedic surgery receive 3.9% of all packed red blood cell transfusions in the UK. Bleeding and the need for allogeneic blood transfusions has been shown to increase the risk of surgical site infection and mortality, and is associated with an increased duration of hospital stay and costs associated with surgery. Reducing blood loss during surgery may reduce the risk of allogeneic blood transfusion, reduce costs and improve outcomes following surgery. Several pharmacological interventions are available and currently employed as part of routine clinical care. OBJECTIVES To determine the relative efficacy of pharmacological interventions for preventing blood loss in elective primary or revision hip or knee replacement, and to identify optimal administration of interventions regarding timing, dose and route, using network meta-analysis (NMA) methodology. SEARCH METHODS We searched the following databases for randomised controlled trials (RCTs) and systematic reviews, from inception to 18 October 2022: CENTRAL (the Cochrane Library), MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Transfusion Evidence Library (Evidentia), ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP). SELECTION CRITERIA We included RCTs of people undergoing elective hip or knee surgery only. We excluded non-elective or emergency procedures, and studies published since 2010 that had not been prospectively registered (Cochrane Injuries policy). There were no restrictions on gender, ethnicity or age (adults only). We excluded studies that used standard of care as the comparator. Eligible interventions included: antifibrinolytics (tranexamic acid (TXA), aprotinin, epsilon-aminocaproic acid (EACA)), desmopressin, factor VIIa and XIII, fibrinogen, fibrin sealants and non-fibrin sealants. DATA COLLECTION AND ANALYSIS We performed the review according to standard Cochrane methodology. Two authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using CINeMA. We presented direct (pairwise) results using RevMan Web and performed the NMA using BUGSnet. We were interested in the following primary outcomes: need for allogenic blood transfusion (up to 30 days) and all-cause mortality (deaths occurring up to 30 days after the operation), and the following secondary outcomes: mean number of transfusion episodes per person (up to 30 days), re-operation due to bleeding (within seven days), length of hospital stay and adverse events related to the intervention received. MAIN RESULTS We included a total of 102 studies. Twelve studies did not report the number of included participants; the other 90 studies included 8418 participants. Trials included more women (64%) than men (36%). In the NMA for allogeneic blood transfusion, we included 47 studies (4398 participants). Most studies examined TXA (58 arms, 56%). We found that TXA, given intra-articularly and orally at a total dose of greater than 3 g pre-incision, intraoperatively and postoperatively, ranked the highest, with an anticipated absolute effect of 147 fewer blood transfusions per 1000 people (150 fewer to 104 fewer) (53% chance of ranking 1st) within the NMA (risk ratio (RR) 0.02, 95% credible interval (CrI) 0 to 0.31; moderate-certainty evidence). This was followed by TXA given orally at a total dose of 3 g pre-incision and postoperatively (RR 0.06, 95% CrI 0.00 to 1.34; low-certainty evidence) and TXA given intravenously and orally at a total dose of greater than 3 g intraoperatively and postoperatively (RR 0.10, 95% CrI 0.02 to 0.55; low-certainty evidence). Aprotinin (RR 0.59, 95% CrI 0.36 to 0.96; low-certainty evidence), topical fibrin (RR 0.86, CrI 0.25 to 2.93; very low-certainty evidence) and EACA (RR 0.60, 95% CrI 0.29 to 1.27; very low-certainty evidence) were not shown to be as effective compared with TXA at reducing the risk of blood transfusion. We were unable to perform an NMA for our primary outcome all-cause mortality within 30 days of surgery due to the large number of studies with zero events, or because the outcome was not reported. In the NMA for deep vein thrombosis (DVT), we included 19 studies (2395 participants). Most studies examined TXA (27 arms, 64%). No studies assessed desmopressin, EACA or topical fibrin. We found that TXA given intravenously and orally at a total dose of greater than 3 g intraoperatively and postoperatively ranked the highest, with an anticipated absolute effect of 67 fewer DVTs per 1000 people (67 fewer to 34 more) (26% chance of ranking first) within the NMA (RR 0.16, 95% CrI 0.02 to 1.43; low-certainty evidence). This was followed by TXA given intravenously and intra-articularly at a total dose of 2 g pre-incision and intraoperatively (RR 0.21, 95% CrI 0.00 to 9.12; low-certainty evidence) and TXA given intravenously and intra-articularly, total dose greater than 3 g pre-incision, intraoperatively and postoperatively (RR 0.13, 95% CrI 0.01 to 3.11; low-certainty evidence). Aprotinin was not shown to be as effective compared with TXA (RR 0.67, 95% CrI 0.28 to 1.62; very low-certainty evidence). We were unable to perform an NMA for our secondary outcomes pulmonary embolism, myocardial infarction and CVA (stroke) within 30 days, mean number of transfusion episodes per person (up to 30 days), re-operation due to bleeding (within seven days), or length of hospital stay, due to the large number of studies with zero events, or because the outcome was not reported by enough studies to build a network. There are 30 ongoing trials planning to recruit 3776 participants, the majority examining TXA (26 trials). AUTHORS' CONCLUSIONS We found that of all the interventions studied, TXA is probably the most effective intervention for preventing bleeding in people undergoing hip or knee replacement surgery. Aprotinin and EACA may not be as effective as TXA at preventing the need for allogeneic blood transfusion. We were not able to draw strong conclusions on the optimal dose, route and timing of administration of TXA. We found that TXA given at higher doses tended to rank higher in the treatment hierarchy, and we also found that it may be more beneficial to use a mixed route of administration (oral and intra-articular, oral and intravenous, or intravenous and intra-articular). Oral administration may be as effective as intravenous administration of TXA. We found little to no evidence of harm associated with higher doses of tranexamic acid in the risk of DVT. However, we are not able to definitively draw these conclusions based on the trials included within this review.
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Affiliation(s)
- Victoria N Gibbs
- Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
| | - Rita Champaneria
- Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
- Nuffield Department of Clinical Laboratory Sciences, University of Oxford, Oxford, UK
| | - Josie Sandercock
- Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
- Nuffield Department of Clinical Laboratory Sciences, University of Oxford, Oxford, UK
| | - Nicky J Welton
- Bristol Medical School, University of Bristol, Bristol, UK
| | - Louise J Geneen
- Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
- Nuffield Department of Clinical Laboratory Sciences, University of Oxford, Oxford, UK
| | - Susan J Brunskill
- Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
- Nuffield Department of Clinical Laboratory Sciences, University of Oxford, Oxford, UK
| | - Carolyn Dorée
- Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
- Nuffield Department of Clinical Laboratory Sciences, University of Oxford, Oxford, UK
| | - Catherine Kimber
- Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
- Nuffield Department of Clinical Laboratory Sciences, University of Oxford, Oxford, UK
| | - Antony Jr Palmer
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Lise J Estcourt
- Haematology/Transfusion Medicine, NHS Blood and Transplant, Oxford, UK
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Lin YK, Tsai SW, Wu PK, Chen CM, Yang JCS, Chen CF, Chen WM. Significantly reducing blood loss via a peri-articular injection of tranexamic acid during total knee arthroplasty: a retrospective study. BMC Musculoskelet Disord 2021; 22:703. [PMID: 34404381 PMCID: PMC8369734 DOI: 10.1186/s12891-021-04591-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/19/2020] [Accepted: 08/04/2021] [Indexed: 11/23/2022] Open
Abstract
BACKGROUND The administration of an intra-articular injection (IAI) of tranexamic acid (TXA) has been demonstrated to be effective in reducing both blood loss and transfusion rate during total knee arthroplasty (TKA); however, few studies have reported the efficiency of a peri-articular injection (PAI) of TXA. We studied the efficiency of a PAI of TXA in reducing blood loss during TKA. METHODS Fifty patients undergoing primary simultaneous bilateral TKA were enrolled in this retrospective study. The right knee received a PAI of 1 g of TXA (Group I), and the left knee received an IAI of 1 g of TXA (Group II). The clinical outcome measures were a change in blood loss from Hemovac drains and surgical time. RESULTS The decrease in blood loss from the Hemovac was significantly lower in Group I (460.1 ± 36.79 vs. 576.0 ± 34.01, P < 0.001) than in Group II, and no significant difference in surgical times was observed. The blood transfusion rate in the present study was 16 %. CONCLUSIONS A PAI of TXA may reduce blood loss more efficiently than an IAI of TXA during TKA without increased complications such as surgical site infection, poor wound healing, skin necrosis, pulmonary embolism, and deep vein thrombosis.
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Affiliation(s)
- Yu-Kuan Lin
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taoyuan branch, No. 100, Sec. 3, Cheng-Kung Road, 330, Taoyuan, Taiwan, Republic of China
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, 18F, No. 201, Sec. 2, Shih-Pai Road, 112, Taipei, Taiwan, Republic of China
- College of Biomedical Science and Engineering, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
| | - Shang-Wen Tsai
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, 18F, No. 201, Sec. 2, Shih-Pai Road, 112, Taipei, Taiwan, Republic of China
- Orthopaedic Department School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
| | - Po-Kuei Wu
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, 18F, No. 201, Sec. 2, Shih-Pai Road, 112, Taipei, Taiwan, Republic of China
- Orthopaedic Department School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
- Institute of Clinical Medicine, School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
| | - Chao-Ming Chen
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, 18F, No. 201, Sec. 2, Shih-Pai Road, 112, Taipei, Taiwan, Republic of China
- Orthopaedic Department School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
- Institute of Clinical Medicine, School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
| | - Jesse Chieh-Szu Yang
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, 18F, No. 201, Sec. 2, Shih-Pai Road, 112, Taipei, Taiwan, Republic of China
- Orthopaedic Department School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
- Institute of Clinical Medicine, School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
| | - Cheng-Fong Chen
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, 18F, No. 201, Sec. 2, Shih-Pai Road, 112, Taipei, Taiwan, Republic of China.
- Orthopaedic Department School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China.
| | - Wei-Ming Chen
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, 18F, No. 201, Sec. 2, Shih-Pai Road, 112, Taipei, Taiwan, Republic of China
- Orthopaedic Department School of Medicine, National Yang Ming Chiao Tung University, No. 155, Sec. 2, Linong Street, 112, Taipei, Taiwan, Republic of China
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Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, Politis C, Jacobs R, Verhamme P. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J 2021; 19:54. [PMID: 34380507 PMCID: PMC8356407 DOI: 10.1186/s12959-021-00303-9] [Citation(s) in RCA: 41] [Impact Index Per Article: 10.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2021] [Accepted: 07/08/2021] [Indexed: 12/12/2022] Open
Abstract
OBJECTIVES We review the evidence for tranexamic acid (TXA) for the treatment and prevention of bleeding caused by surgery, trauma and bleeding disorders. We highlight therapeutic areas where evidence is lacking and discuss safety issues, particularly the concern regarding thrombotic complications. METHODS An electronic search was performed in PubMed and the Cochrane Library to identify clinical trials, safety reports and review articles. FINDINGS TXA reduces bleeding in patients with menorrhagia, and in patients undergoing caesarian section, myomectomy, hysterectomy, orthopedic surgery, cardiac surgery, orthognathic surgery, rhinoplasty, and prostate surgery. For dental extractions in patients with bleeding disorders or taking antithrombotic drugs, as well as in cases of idiopathic epistaxis, tonsillectomy, liver transplantation and resection, nephrolithotomy, skin cancer surgery, burn wounds and skin grafting, there is moderate evidence that TXA is effective for reducing bleeding. TXA was not effective in reducing bleeding in traumatic brain injury and upper and lower gastrointestinal bleeding. TXA reduces mortality in patients suffering from trauma and postpartum hemorrhage. For many of these indications, there is no consensus about the optimal TXA dose. With certain dosages and with certain indications TXA can cause harm, such as an increased risk of seizures after high TXA doses with brain injury and cardiac surgery, and an increased mortality after delayed administration of TXA for trauma events or postpartum hemorrhage. Whereas most trials did not signal an increased risk for thrombotic events, some trials reported an increased rate of thrombotic complications with the use of TXA for gastro-intestinal bleeding and trauma. CONCLUSIONS TXA has well-documented beneficial effects in many clinical indications. Identifying these indications and the optimal dose and timing to minimize risk of seizures or thromboembolic events is work in progress.
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Affiliation(s)
- Anna Ockerman
- Department of Imaging and Pathology, KU Leuven, OMFS-IMPATH Research Group, Leuven, Belgium.
- Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.
| | - Thomas Vanassche
- Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium
| | - Melisa Garip
- Department of Imaging and Pathology, KU Leuven, OMFS-IMPATH Research Group, Leuven, Belgium
- Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium
| | | | | | - Jeroen Martens
- Department of Imaging and Pathology, KU Leuven, OMFS-IMPATH Research Group, Leuven, Belgium
- Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium
| | - Constantinus Politis
- Department of Imaging and Pathology, KU Leuven, OMFS-IMPATH Research Group, Leuven, Belgium
- Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium
| | - Reinhilde Jacobs
- Department of Imaging and Pathology, KU Leuven, OMFS-IMPATH Research Group, Leuven, Belgium
- Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium
- Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden
| | - Peter Verhamme
- Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium
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Belk JW, McCarty EC, Houck DA, Dragoo JL, Savoie FH, Thon SG. Tranexamic Acid Use in Knee and Shoulder Arthroscopy Leads to Improved Outcomes and Fewer Hemarthrosis-Related Complications: A Systematic Review of Level I and II Studies. Arthroscopy 2021; 37:1323-1333. [PMID: 33278534 DOI: 10.1016/j.arthro.2020.11.051] [Citation(s) in RCA: 23] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Revised: 11/18/2020] [Accepted: 11/19/2020] [Indexed: 02/02/2023]
Abstract
PURPOSE To systematically review the literature to compare the efficacy and safety of tranexamic acid (TXA) as a means to minimize hemarthrosis-related complications after arthroscopic procedures of the knee, hip, and shoulder. METHODS A systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed by searching PubMed, Cochrane Library, and Embase databases to locate randomized controlled trials comparing the clinical outcomes and postoperative complications of patients undergoing arthroscopy with and without TXA. Search terms used were "tranexamic acid," "arthroscopy," "knee," "hip," and "shoulder." Patients were evaluated based on early (<6 weeks) postoperative signs of hemarthrosis using the Coupens and Yates classification, postoperative complications (myocardial infarction, stroke, venous thromboembolism events), range of motion (ROM), and patient-reported outcome scores (Visual analog scale, Subjective International Knee Documentation Committee, Lysholm, and Tegner activity scores). RESULTS Five studies (2 level I and 3 level II) met inclusion criteria, including a total of 299 patients undergoing arthroscopy with TXA and 299 patients without TXA. The average follow-up duration for all patients was 43.9 days. Procedures performed were partial meniscectomy, anterior cruciate ligament reconstruction, and rotator cuff repair. No studies evaluating TXA use in hip arthroscopy were identified. Coupens-Yates hemarthrosis grades significantly improved in the TXA groups across all studies. Three studies found TXA patients to experience significantly less postoperative pain at latest follow-up, 1 study found TXA patients to have significantly better postoperative Lysholm scores, and 1 study found TXA patients to have significantly more ROM at latest follow-up compared with non-TXA patients (P < .05). CONCLUSION Patients undergoing arthroscopy, particularly arthroscopic meniscectomy, arthroscopic-assisted anterior cruciate ligament reconstruction, and arthroscopic rotator cuff repair, with TXA can be expected to experience improved outcomes and less hemarthrosis-related complications in the early postoperative period compared with non-TXA patients. LEVEL OF EVIDENCE II, systematic review of level I and II studies.
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Affiliation(s)
- John W Belk
- Department of Orthopaedics, University of Colorado School of Medicine, Aurora, Colorado, U.S.A..
| | - Eric C McCarty
- Department of Orthopaedics, University of Colorado School of Medicine, Aurora, Colorado, U.S.A
| | - Darby A Houck
- Department of Orthopaedics, University of Colorado School of Medicine, Aurora, Colorado, U.S.A
| | - Jason L Dragoo
- Department of Orthopaedics, University of Colorado School of Medicine, Aurora, Colorado, U.S.A
| | - Felix H Savoie
- Department of Orthopaedics, Tulane University, New Orleans, Louisiana, U.S.A
| | - Stephen G Thon
- Department of Orthopaedics, University of Colorado School of Medicine, Aurora, Colorado, U.S.A
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Reale D, Andriolo L, Gursoy S, Bozkurt M, Filardo G, Zaffagnini S. Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials. BIOMED RESEARCH INTERNATIONAL 2021; 2021:6961540. [PMID: 33532495 PMCID: PMC7834786 DOI: 10.1155/2021/6961540] [Citation(s) in RCA: 24] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/22/2020] [Accepted: 12/23/2020] [Indexed: 12/21/2022]
Abstract
OBJECTIVE Tranexamic acid (TXA) is increasingly used in orthopedic surgery to reduce blood loss; however, there are concerns about the risk of venous thromboembolic (VTE) complications. The aim of this study was to evaluate TXA safety in patients undergoing lower limb orthopedic surgical procedures. DESIGN A meta-analysis was performed on the PubMed, Web of Science, and Cochrane Library databases in January 2020 using the following string (Tranexamic acid) AND ((knee) OR (hip) OR (ankle) OR (lower limb)) to identify RCTs about TXA use in patients undergoing every kind of lower limb surgical orthopedic procedures, with IV, IA, or oral administration, and compared with a control arm to quantify the VTE complication rates. RESULTS A total of 140 articles documenting 9,067 patients receiving TXA were identified. Specifically, 82 studies focused on TKA, 41 on THA, and 17 on other surgeries, including anterior cruciate ligament reconstruction, intertrochanteric fractures, and meniscectomies. The intravenous TXA administration protocol was studied in 111 articles, the intra-articular in 45, and the oral one in 7 articles. No differences in terms of thromboembolic complications were detected between the TXA and control groups neither in the overall population (2.4% and 2.8%, respectively) nor in any subgroup based on the surgical procedure and TXA administration route. CONCLUSIONS There is an increasing interest in TXA use, which has been recently broadened from the most common joint replacement procedures to the other types of surgeries. Overall, TXA did not increase the risk of VTE complications, regardless of the administration route, thus supporting the safety of using TXA for lower limb orthopedic surgical procedures.
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Affiliation(s)
- Davide Reale
- Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
| | - Luca Andriolo
- Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
| | - Safa Gursoy
- Department of Orthopaedics and Traumatology, Ankara Yildirim Beyazit University, Ankara, Turkey
| | - Murat Bozkurt
- Department of Orthopaedics and Traumatology, Ankara Yildirim Beyazit University, Ankara, Turkey
| | - Giuseppe Filardo
- Applied and Translational Research Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
- Facoltà di Scienze Biomediche, Università della Svizzera Italiana, Lugano, Switzerland
| | - Stefano Zaffagnini
- Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
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Tranexamic Acid Reduces Total Blood Loss and Inflammatory Response in Computer-Assisted Navigation Total Knee Arthroplasty. BIOMED RESEARCH INTERNATIONAL 2019; 2019:5207517. [PMID: 31886224 PMCID: PMC6925782 DOI: 10.1155/2019/5207517] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 04/18/2019] [Accepted: 09/11/2019] [Indexed: 11/18/2022]
Abstract
Introduction Tranexamic acid (TXA) is an effective blood salvage agent that reduces perioperative blood loss in conventional total knee arthroplasty (TKA). As computer-assisted surgery for TKA (CAS-TKA) results in a lower perioperative blood loss than conventional TKA, the additional effect of blood conservation by TXA might be mitigated. This study aimed to evaluate the efficacy of TXA in CAS-TKA. Methods We retrospectively reviewed 222 consecutive patients who underwent CAS-TKA. Intravenous TXA was administered in 103 patients (TXA group) at a dosage of 20 mg/kg 15 min before deflation of the tourniquet. The other 119 patients did not receive TXA (control group). Patient demographic data including age, gender, BMI, DM, and hypertension were collected. The primary outcomes were the estimated total blood loss (ETBL) and perioperative data, including tourniquet duration, preoperative and postoperative day 1 (POD1) and day 3 (POD3) serum D-dimer, CRP, hemoglobin (Hb), and hematocrit (Hct) levels. Secondary outcomes including transfusion rate and 90-day complications were recorded. Results The ETBL was lower in the TXA group on both POD1 (404.34 ± 234.77 vs. 595.47 ± 279.04, p < 0.001) and POD3 (761.39 ± 260.88 vs. 987.79 ± 326.58, p < 0.001). The TXA group also demonstrated a lower level of CRP on POD1 (p=0.02) and lower levels of CRP and serum D-dimer on POD3 (p=0.008 and p < 0.001). Consumption of fibrinogen was higher in the control group on both POD1 (p=0.013) and POD3 (p < 0.001). Length of hospital stay was lower in the TXA group (5.42 ± 1.21 vs. 6.25 ± 1.49, p < 0.001). The transfusion rate and perioperative complications were not significantly different between the two groups. Conclusion Administration of TXA is not only effective in reducing perioperative blood loss and length of hospital stay but also exerts an anti-inflammatory effect following CAS-TKA without causing major complications.
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Pavão DM, Palhares GM, Albuquerque RSPE, de Sousa EB, Barretto JM. Prospective Study on the Impact of the Use of Human Fibrin Sealant free of Clot-Stabilizing Agents in Total Knee Arthroplasty. Rev Bras Ortop 2019; 54:322-328. [PMID: 31363288 PMCID: PMC6597421 DOI: 10.1055/s-0039-1692447] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2018] [Accepted: 07/10/2018] [Indexed: 11/18/2022] Open
Abstract
Objective The present study aimed to evaluate the results of the intraoperative topical use of a human fibrin sealant free of clot-stabilizing agents in total knee arthroplasties (TKAs), looking for differences between groups regarding blood loss, transfusion requirement, length of hospital stay, pain perception, range of motion (ROM), and incidence of complications. Methods We have analyzed prospectively an intervention group with 32 patients (Sealant) and a control group with 31 patients (Control) with symptomatic knee osteoarthritis who underwent TKA. Results The results were similar between the groups regarding visible blood loss in the drain in 24 hours (Control, 276.5 mL ± 46.24 versus Sealant, 365.9 mL ± 45.73), total blood loss in 24 hours (Control, 930 mL ± 78 versus Sealant, 890 mL ± 67) and in 60 hours after surgery (Control, 1,250 mL ± 120 versus Sealant, 1,190 mL ± 96), blood transfusion requirement (which occurred only in 1 control patient), length of hospital days stay (Control, 5.61 ± 0.50 versus Sealant, 4.81 ± 0.36), postoperative pain, and ROM. Sealant use was not related to wound healing complications, to infection, or to deep venous thrombosis. Conclusion We have concluded that the hemostatic agent composed of human fibrin was not effective in reducing bleeding volume and blood transfusion requirement, nor it interfered with hospital length of stay, pain perception, and ROM. Its use was not related to any complications.
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Affiliation(s)
- Douglas Mello Pavão
- Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad, Rio de Janeiro, RJ, Brasil
| | | | | | | | - João Maurício Barretto
- Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad, Rio de Janeiro, RJ, Brasil
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9
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Safety of intravenous tranexamic acid in patients undergoing majororthopaedic surgery: a meta-analysis of randomised controlled trials. BLOOD TRANSFUSION = TRASFUSIONE DEL SANGUE 2018. [PMID: 29337665 DOI: 10.2450//2017.0219-17] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
Among the various pharmacological options to decrease peri-operative bleeding, tranexamic acid appears to be one of the most interesting. Several trials have consistently documented the efficacy of this synthetic drug in reducing the risk of blood loss and the need for allogeneic blood transfusion in patients undergoing total hip and knee arthroplasty. The safety of intravenous tranexamic acid in major orthopaedic surgery, particularly regarding the risk of venous thromboembolism, was systematically analysed in this review. A systematic search of the literature identified 73 randomised controlled trials involving 4,174 patients and 2,779 controls. The raw overall incidence of venous thromboembolism was 2.1% in patients who received intravenous tranexamic acid and 2.0% in controls. A meta-analytic pooling showed that the risk of venous thromboembolism in tranexamic acid-treated patients was not significantly different from that of controls (risk difference: 0.01%, 95% confidence interval [CI]: -0.05%, 0.07%; risk ratio: 1.067, 95% CI: 0.760-1.496). Other severe drug-related adverse events occurred very rarely (0.1%). In conclusion, the results of this systematic review and meta-analysis show that intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopaedic surgery.
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10
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Yates J, Perelman I, Khair S, Taylor J, Lampron J, Tinmouth A, Saidenberg E. Exclusion criteria and adverse events in perioperative trials of tranexamic acid: a systematic review and meta-analysis. Transfusion 2018; 59:806-824. [PMID: 30516835 DOI: 10.1111/trf.15030] [Citation(s) in RCA: 34] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2018] [Revised: 10/01/2018] [Accepted: 10/06/2018] [Indexed: 12/12/2022]
Abstract
BACKGROUND Tranexamic acid (TXA) is an inexpensive therapy effective at minimizing perioperative blood loss and transfusion. However, it remains underutilized due to safety concerns. To date, no evidence-based guidelines exist identifying which patients should not receive TXA therapy. This study determined patient groups for whom safety information regarding TXA is lacking due to common exclusion from perioperative TXA trials. STUDY DESIGN AND METHODS A systematic review searching the databases Medline, EMBASE, CENTRAL, and Clinicaltrials.gov was performed. Randomized controlled trials (RCTs) administering systemic TXA perioperatively to elective or emergent surgery patients were eligible. Our primary outcome was to describe exclusion criteria of RCTs, and the secondary outcome was TXA safety. A descriptive synthesis of exclusion criteria was performed, and TXA safety was assessed by meta-analysis. RESULTS A total of 268 eligible RCTs were included. Meta-analysis showed that systemic TXA did not increase risk of adverse events compared to placebo or no intervention (relative risk, 1.05; 95% confidence interval, 0.99-1.12). Patient groups commonly excluded from perioperative TXA trials, and thus potentially lacking TXA safety data, were those with major comorbidities, a history of thromboembolism, medication use affecting coagulation, TXA allergy, and coagulopathy. Exclusion of patients with major comorbidities may not be necessary; we showed that the risk of adverse events was similar in studies that excluded patients with major comorbidities and those that did not. CONCLUSION Sufficient evidence exists to develop perioperative guidelines for TXA use in many populations. Further studies evaluating perioperative TXA use in patients with a history of thromboembolism are warranted.
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Affiliation(s)
- Jeffrey Yates
- Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Iris Perelman
- Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.,Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Simonne Khair
- Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Joshua Taylor
- Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Jacinthe Lampron
- Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.,Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.,Ottawa Hospital, Ottawa, Ontario, Canada
| | - Alan Tinmouth
- Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.,Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.,Ottawa Hospital, Ottawa, Ontario, Canada
| | - Elianna Saidenberg
- Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.,Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.,Ottawa Hospital, Ottawa, Ontario, Canada
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11
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Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Shores P, Mullen K, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. The Efficacy of Tranexamic Acid in Total Knee Arthroplasty: A Network Meta-Analysis. J Arthroplasty 2018; 33:3090-3098.e1. [PMID: 29805106 DOI: 10.1016/j.arth.2018.04.043] [Citation(s) in RCA: 156] [Impact Index Per Article: 22.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2018] [Revised: 04/24/2018] [Accepted: 04/26/2018] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND A growing body of published research on tranexamic acid (TXA) suggests that it is effective in reducing blood loss and the risk for transfusion in total knee arthroplasty (TKA). The purpose of this network meta-analysis was to evaluate TXA in primary TKA as the basis for the efficacy recommendations of the combined clinical practice guidelines of the American Association of Hip and Knee Surgeons, American Academy of Orthopaedic Surgeons, Hip Society, Knee Society, and American Society of Regional Anesthesia and Pain Medicine on the use of TXA in primary total joint arthroplasty. METHODS We searched Ovid MEDLINE, Embase, Cochrane Reviews, Scopus, and Web of Science databases for publications before July 2017 on TXA in primary total joint arthroplasty. All included studies underwent qualitative and quantitative homogeneity testing. Direct and indirect comparisons were performed as a network meta-analysis, and results were tested for consistency. RESULTS After critical appraisal of the available 2113 publications, 67 articles were identified as representing the best available evidence. Topical, intravenous (IV), and oral TXA formulations were all superior to placebo in terms of decreasing blood loss and risk of transfusion, while no formulation was clearly superior. Use of repeat IV and oral TXA dosing and higher doses of IV and topical TXA did not significantly reduce blood loss or risk of transfusion. Preincision administration of IV TXA had inconsistent findings with a reduced risk of transfusion but no effect on volume of blood loss. CONCLUSIONS Strong evidence supports the efficacy of TXA to decrease blood loss and the risk of transfusion after primary TKA. No TXA formulation, dosage, or number of doses provided clearly improved blood-sparing properties for TKA. Moderate evidence supports preincision administration of IV TXA to improve efficacy.
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Affiliation(s)
- Yale A Fillingham
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Dipak B Ramkumar
- Department of Orthopaedic Surgery, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
| | - David S Jevsevar
- Department of Orthopaedic Surgery, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
| | - Adolph J Yates
- Department of Orthopaedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
| | - Peter Shores
- Department of Research, Quality, and Scientific Affairs, American Academy of Orthopaedic Surgeons, Rosemont, Illinois
| | - Kyle Mullen
- Department of Research, Quality, and Scientific Affairs, American Academy of Orthopaedic Surgeons, Rosemont, Illinois
| | - Stefano A Bini
- Department of Orthopaedic Surgery, University of California San Francisco, San Francisco, California
| | - Henry D Clarke
- Department of Orthopaedic Surgery, Mayo Clinic, Phoenix, Arizona
| | - Emil Schemitsch
- Department of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada
| | - Rebecca L Johnson
- Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota
| | | | - Siraj A Sayeed
- South Texas Bone and Joint Institute, San Antonio, Texas
| | | | - Craig J Della Valle
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
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12
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Verra WC, van Hilten JA, Honohan Á, van Zwet EW, van der Bom JG, Nelissen RGHH, on behalf of the FIRST-research group. The effect of a fibrin sealant on knee function after total knee replacement surgery. Results from the FIRST trial. A multicenter randomized controlled trial. PLoS One 2018; 13:e0200804. [PMID: 30044846 PMCID: PMC6059473 DOI: 10.1371/journal.pone.0200804] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2017] [Accepted: 06/28/2018] [Indexed: 11/18/2022] Open
Abstract
Background Total knee replacement (TKR) is increasingly performed in short term hospital stay, making same day mobilization an important issue is after surgery. This implies little joint effusion by reducing intra-articular blood loss, which will enhance knee range of motion. The application of a topical fibrin sealant on the intraoperative bare bone and synovial tissue may contribute to better early full mobilization and thus improved functional outcomes. Since ambulation with a fully extended knee is less strenuous, we hypothesized that patients who received fibrin sealant would demonstrate improved early knee extension after six weeks compared to patients who received standard care. Methods A multicenter randomized controlled trial in a consecutive series of osteoarthritis patients scheduled for TKR surgery. Participants were randomized to receive fibrin sealant or not before closing the knee joint capsule. Primary outcome was change in knee extension angle(°) at short term (2 weeks) follow-up (cExt). Secondary outcomes were 6-week extension angle, knee flexion angle, hemoglobin loss, blood transfusion rates, complication rates, the Knee Society Score, and the KOOS and EQ5D questionnaires. Results When data on primary outcome became available from 250 patients, an interim analysis was performed by an independent Data Safety Monitoring Board for safety and effectivity assessment. This analysis showed that sufficient patients were included to detect a cExt of 10° between both groups. Inclusion was stopped however, all in the meantime included patients were treated according to their randomization. A total of 466 were available for analysis. Both groups were comparable in terms of baseline characteristics. The estimated mean cExt difference was 0.2° (95%CI -0.5 to 0.9). No differences in secondary outcomes were found. Conclusions No beneficial effects or side effects were found of a topically applied fibrin sealant during TKR surgery. These results discourage the clinical use of a fibrin sealant in TKR. Trial registration Dutch Trial Register, NTR2500.
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Affiliation(s)
- Wiebe C. Verra
- Department of Orthopedic Surgery, Leiden University Medical Center, Leiden, the Netherlands
- Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands
- * E-mail:
| | - Joost A. van Hilten
- Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands
| | - Áine Honohan
- Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands
| | - Erik W. van Zwet
- Department of Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands
| | - Johanna G. van der Bom
- Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands
| | - Rob G. H. H. Nelissen
- Department of Orthopedic Surgery, Leiden University Medical Center, Leiden, the Netherlands
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13
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Tranexamic acid reduces blood loss and transfusion requirements in primary simultaneous bilateral total knee arthroplasty: a meta-analysis of randomized controlled trials. Blood Coagul Fibrinolysis 2018; 28:501-508. [PMID: 28448319 DOI: 10.1097/mbc.0000000000000637] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
: The aim of this meta-analysis is to assess the effectiveness and safety of intravenous application tranexamic acid (TXA) in primary simultaneous bilateral total knee arthroplasty (TKA). We searched electronic databases including PubMed, Embase, the Web of Science, the Cochrane Library and the Google Scholar, for published studies involving the intravenous application TXA in primary simultaneous bilateral TKA. All randomized controlled trials were included. The focus of the meta-analysis was on the outcomes of total blood loss, drainage volume, transfusion requirements and deep venous thrombosis (DVT) and/or pulmonary embolism. The relevant data were analyzed using RevMan 5.2. Six high randomized controlled trials were included, with a total sample size of 394 patients. The intravenous application of TXA significantly reduced total blood loss [95% confidence interval (CI), -519.52 to -126.40; P = 0.001], drainage volume (95% CI, -551.76 to -138.57; P = 0.001) and transfusion requirements (risk ratio, 0.38; 95% CI, 0.21-0.68; P = 0.001) compared with the control group. In addition, there were no significant differences in the rate of DVT (P = 1.00) and/or pulmonary embolism between the two groups. Based on the current evidence, this meta-analysis showed that intravenous application of TXA is effective and a well tolerated treatment to reduce total blood loss, drainage volume and transfusion requirements without increasing the risk of DVT and/or pulmonary embolism in primary simultaneous bilateral TKA.
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14
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Edwards SJ, Crawford F, van Velthoven MH, Berardi A, Osei-Assibey G, Bacelar M, Salih F, Wakefield V. The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms. Health Technol Assess 2018; 20:1-224. [PMID: 28051764 DOI: 10.3310/hta20940] [Citation(s) in RCA: 30] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022] Open
Abstract
BACKGROUND Fibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use. OBJECTIVES To systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults. DATA SOURCES Electronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015. The websites of regulatory bodies (the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and the Food and Drug Administration) were also searched to identify evidence of harms. REVIEW METHODS This review included randomised controlled trials (RCTs) and observational studies using any type of fibrin sealant compared with standard care in non-emergency surgery in adults. The primary outcome was risk of developing seroma and haematoma. Only RCTs were used to inform clinical effectiveness and both RCTs and observational studies were used for the assessment of harms related to the use of fibrin sealant. Two reviewers independently screened all titles and abstracts to identify potentially relevant studies. Data extraction was undertaken by one reviewer and validated by a second. The quality of included studies was assessed independently by two reviewers using the Cochrane Collaboration risk-of-bias tool for RCTs and the Centre for Reviews and Dissemination guidance for adverse events for observational studies. A fixed-effects model was used for meta-analysis. RESULTS We included 186 RCTs and eight observational studies across 14 surgical specialties and five reports from the regulatory bodies. Most RCTs were judged to be at an unclear risk of bias. Adverse events were inappropriately reported in observational studies. Meta-analysis across non-emergency surgical specialties did not show a statistically significant difference in the risk of seroma for fibrin sealants versus standard care in 32 RCTs analysed [n = 3472, odds ratio (OR) 0.84, 95% confidence interval (CI) 0.68 to 1.04; p = 0.13; I2 = 12.7%], but a statistically significant benefit was found on haematoma development in 24 RCTs (n = 2403, OR 0.62, 95% CI 0.44 to 0.86; p = 0.01; I2 = 0%). Adverse events related to fibrin sealant use were reported in 10 RCTs and eight observational studies across surgical specialties, and 22 RCTs explicitly stated that there were no adverse events. One RCT reported a single death but no other study reported mortality or any serious adverse events. Five regulatory body reports noted death from air emboli associated with fibrin sprays. LIMITATIONS It was not possible to provide a detailed evaluation of individual RCTs in their specific contexts because of the limited resources that were available for this research. In addition, the number of RCTs that were identified made it impractical to conduct independent data extraction by two reviewers in the time available. CONCLUSIONS The effectiveness of fibrin sealants does not appear to vary according to surgical procedures with regard to reducing the risk of seroma or haematoma. Surgeons should note the potential risk of gas embolism if spray application of fibrin sealants is used and not to exceed the recommended pressure and spraying distance. Future research should be carried out in surgery specialties for which only limited data were found, including neurological, gynaecological, oral and maxillofacial, urology, colorectal and orthopaedics surgery (for any outcome); breast surgery and upper gastrointestinal (development of haematoma); and cardiothoracic heart or lung surgery (reoperation rates). In addition, studies need to use adequate sample sizes, to blind participants and outcome assessors, and to follow reporting guidelines. STUDY REGISTRATION This study is registered as PROSPERO CRD42015020710. FUNDING The National Institute for Health Research Health Technology Assessment programme.
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15
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Zhao Z, Ma X, Ma J, Sun X, Li F, Lv J. A Systematic Review and Meta-analysis of the Topical Administration of Fibrin Sealant in Total Hip Arthroplasty. Sci Rep 2018; 8:78. [PMID: 29311570 PMCID: PMC5758515 DOI: 10.1038/s41598-017-16779-3] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2015] [Accepted: 11/15/2017] [Indexed: 11/14/2022] Open
Abstract
Patients who undergo total hip arthroplasty (THA) may experience a large amount of blood loss. The objective of our study is to include randomized controlled trials (RCTs) and compare the clinical outcomes of fibrin sealant (FS) versus placebo after a THA. In October 2015, we searched the following databases: Medline, Embase, PubMed, the Cochrane Controlled Trials Register, Web of Science, the China National Knowledge Infrastructure, the China Wanfang database and Google Scholar. Finally, seven studies that included 679 patients met the inclusion criteria. The meta-analysis indicated that the topical administration of FS was associated with a reduction of the need for transfusion compared to the control group (P = 0.05). And topical FS will reduce total blood loss after THA (P = 0.0003) and blood loss in drainage (P = 0.002). However, there was no significant difference in terms of the intraoperative blood loss (P = 0.62) and the rate of deep venous thrombosis (DVT), fever, pain, anemia, hematoma and oozing. In conclusion, the use of FS in patients who are undergoing THA may reduce perioperative blood loss and attenuate the decrease in Hb. Furthermore, FS do not decrease the intraoperative blood loss without an increase in the risk of postoperative DVT, fever, pain, anemia, hematoma and oozing.
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Affiliation(s)
- Zhihu Zhao
- Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China
- Tianjin Hospital, Tianjin University, Tianjin, 300211, People's Republic of China
| | - Xinlong Ma
- Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China.
- Tianjin Hospital, Tianjin University, Tianjin, 300211, People's Republic of China.
| | - Jianxiong Ma
- Biomechanics Labs of Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China
| | - Xiaolei Sun
- Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China
- Tianjin Hospital, Tianjin University, Tianjin, 300211, People's Republic of China
| | - Fengbo Li
- Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China
- Tianjin Hospital, Tianjin University, Tianjin, 300211, People's Republic of China
| | - Jianwei Lv
- Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China
- Tianjin Hospital, Tianjin University, Tianjin, 300211, People's Republic of China
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16
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Kearns SM, Kuhar HN, Bohl DD, Levine BR. An Aprotinin Containing Fibrin Sealant Does Not Reduce Blood Loss in Total Hip Arthroplasty. J Arthroplasty 2017. [PMID: 28648705 DOI: 10.1016/j.arth.2017.05.040] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Fibrin sealants are topical agents used to reduce perioperative blood loss; however, their efficacy in total hip arthroplasty (THA) remains uncertain. The purpose of this study was to determine if a fibrin sealant containing aprotinin as an antifibrinolytic agent, TISSEEL (Baxter, Deerfield, IL), reduces postoperative blood loss and transfusion during THA when compared with intravenous (IV) tranexamic acid (TXA) and control groups. METHODS Three retrospective uniform cohorts of primary THA procedures were identified, from a prospectively maintained database: 1 group who received TISSEEL, 1 group who received 1 g IV TXA, and 1 group who received neither (control). There were 80 patients in each group. Outcome measures included the lowest measured hemoglobin during postoperative hospitalization, greatest decrease in hemoglobin from preoperative to postoperative values, and blood transfusion rates. RESULTS The minimum postoperative hemoglobin level was significantly lower for TISSEEL patients compared with that of IV TXA patients (P = .021) and no different when compared with that of control patients (P = .134). Patients receiving fibrin sealant had a greater hemoglobin level decrease compared with that of IV TXA (P = .029) and control (P = .036). Postoperative transfusion rates were no different for the group receiving TISSEEL compared with those of control (P = .375) and were statistically greater when compared with those of IV TXA (P = .002). CONCLUSION TISSEEL fibrin sealant does not reduce postoperative blood loss or transfusions; however, IV TXA reduced postoperative transfusions compared with TISSEEL and control. Therefore, TXA is recommended to reduce perioperative blood loss, while, utilization of a fibrin sealant requires further refinements before being adopted for routine use in THA.
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Affiliation(s)
- Sean M Kearns
- Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Hannah N Kuhar
- Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Daniel D Bohl
- Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Brett R Levine
- Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois
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17
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Sridharan K, Sivaramakrishnan G. Tranexamic Acid in Total Knee Arthroplasty: Mixed Treatment Comparisons and Recursive Cumulative Meta-Analysis of Randomized, Controlled Trials and Cohort Studies. Basic Clin Pharmacol Toxicol 2017; 122:111-119. [DOI: 10.1111/bcpt.12847] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2017] [Accepted: 07/04/2017] [Indexed: 12/13/2022]
Affiliation(s)
- Kannan Sridharan
- Pharmacology; School of Health Sciences; College of Medicine, Nursing and Health Sciences; Fiji National University; Suva Fiji Islands
| | - Gowri Sivaramakrishnan
- Prosthodontics; School of Oral Health; College of Medicine, Nursing and Health Sciences; Fiji National University; Suva Fiji Islands
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18
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Themistoklis T, Theodosia V, Konstantinos K, Georgios DI. Perioperative blood management strategies for patients undergoing total knee replacement: Where do we stand now? World J Orthop 2017; 8:441-454. [PMID: 28660135 PMCID: PMC5478486 DOI: 10.5312/wjo.v8.i6.441] [Citation(s) in RCA: 42] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2017] [Revised: 03/20/2017] [Accepted: 04/10/2017] [Indexed: 02/06/2023] Open
Abstract
Total knee replacement (TKR) is one of the most common surgeries over the last decade. Patients undergoing TKR are at high risk for postoperative anemia and furthermore for allogeneic blood transfusions (ABT). Complications associated with ABT including chills, rigor, fever, dyspnea, light-headedness should be early recognized in order to lead to a better prognosis. Therefore, perioperative blood management program should be adopted with main aim to reduce the risk of blood transfusion while maximizing hemoglobin simultaneously. Many blood conservation strategies have been attempted including preoperative autologous blood donation, acute normovolemic haemodilution, autologous blood transfusion, intraoperative cell saver, drain clamping, pneumatic tourniquet application, and the use of tranexamic acid. For practical and clinical reasons we will try to classify these strategies in three main stages/pillars: Pre-operative optimization, intra-operative and post-operative protocols. The aim of this work is review the strategies currently in use and reports our experience regarding the perioperative blood management strategies in TKR.
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20
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Song EK, Seon JK, Prakash J, Seol YJ, Park YJ, Jin C. Combined Administration of IV and Topical Tranexamic Acid is Not Superior to Either Individually in Primary Navigated TKA. J Arthroplasty 2017; 32:37-42. [PMID: 27633946 DOI: 10.1016/j.arth.2016.06.052] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/19/2016] [Revised: 06/18/2016] [Accepted: 06/23/2016] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND In this study, we tried to assess if combined method (intravenous [IV] and topical) of tranexamic acid (TXA) administration, which has been shown to be superior in conventional arthroplasty, has similar effect in navigational arthroplasty compared to administration of drug either individually. METHODS In present randomized control trial, 200 patients were randomly divided in one of the 4 groups using computer-generated tables-control, IV, intraarticular, and combined. We studied evident loss through drain, total loss based on Gross method and hemoglobin balance method, hidden losses, hemoglobin and hematocrit drop, functional scores, and all possible complications related to TXA. RESULTS Evident loss in combined group was 535.55 mL, not significantly less than IV (585 mL, P = .15) and intraarticular group (514 mL, P = .74). However, these were significantly less than control group (696 mL, P = .000). Functional scores and recovery rates were, however, comparable in all 4 groups. No patients in any group developed symptomatic deep vein thrombosis. CONCLUSION Tranexamic use decreases blood loss in navigation-assisted arthroplasty, however, less than that observed for conventional arthroplasty in literature. Further, combined group has no added advantage over other methods of drug administration. We believe that additional amount of TXA administered in combined regimen may not be clinically useful. Further TXA group did not have any advantage in terms of functional recovery over control group.
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Affiliation(s)
- Eun-Kyoo Song
- Department of Orthopaedic Surgery, Chonnam National University Bitgoeul Hospital, Gwangju, South Korea
| | - Jong-Keun Seon
- Department of Orthopaedic Surgery, Chonnam National University Bitgoeul Hospital, Gwangju, South Korea
| | - Jatin Prakash
- Department of Orthopaedic Surgery, Chonnam National University Bitgoeul Hospital, Gwangju, South Korea
| | - Young-Jun Seol
- Department of Orthopaedic Surgery, Chonnam National University Hospital, Gwangju, South Korea
| | - Yong Jin Park
- Department of Orthopaedic Surgery, Chonnam National University Bitgoeul Hospital, Gwangju, South Korea
| | - Cheng Jin
- Department of Orthopaedic Surgery, Chonnam National University Bitgoeul Hospital, Gwangju, South Korea
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Wang Z, Xiao L, Guo H, Zhao G, Ma J. The efficiency and safety of fibrin sealant for reducing blood loss in primary total hip arthroplasty: A systematic review and meta-analysis. Int J Surg 2016; 37:50-57. [PMID: 27939268 DOI: 10.1016/j.ijsu.2016.12.007] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2016] [Revised: 12/01/2016] [Accepted: 12/04/2016] [Indexed: 11/27/2022]
Abstract
OBJECTIVE Total hip arthroplasty (THA) is associated with substantial blood loss. The objective of present systematic review and meta-analysis is to provide evidence from randomized controlled trials (RCTs) on the efficiency and safety of administration of fibrin sealant (FS) for reducing blood loss in patients undergoing primary THA. METHODS Potential relevant studies were identified from electronic databases including Medline, PubMed, Embase, ScienceDirect, web of science and Cochrane Library. Gray academic studies were also identified from the reference list of included studies. There was no language restriction. Pooling of data was carried out by using RevMan 5.1. RESULTS Six randomized controlled trials (RCTs) met the inclusion criteria. Current meta-analysis indicated that there were significant differences in terms of total blood loss (MD = -153.77, 95% CI: -287.21 to -20.34, P = 0.02), postoperative hemoglobin level (MD = -0.25, 95% CI: -0.46 to -0.05, P = 0.02) and transfusion rate (RD = -0.12, 95% CI: -0.22 to -0.03, P = 0.01) between groups. No significant differences were found regarding the incidence of deep venous thrombosis (DVT) (RD = 0.00, 95% CI: -0.01to 0.01, P = 0.51) or other side effects. CONCLUSION Administration of fibrin sealant in total hip arthroplasty may reduce total blood loss, postoperative hemoglobin decline and transfusion requirements. Moreover, no adverse effect was related to FS. Due to the limited quality of the evidence currently available, higher quality RCTs are required.
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Affiliation(s)
- Zhiyuan Wang
- Hong-Hui Hospital, Xi'an Jiaotong University College of Medicine, 710054, PR China
| | - Lin Xiao
- Hong-Hui Hospital, Xi'an Jiaotong University College of Medicine, 710054, PR China
| | - Hao Guo
- Hong-Hui Hospital, Xi'an Jiaotong University College of Medicine, 710054, PR China
| | - Guanghui Zhao
- Hong-Hui Hospital, Xi'an Jiaotong University College of Medicine, 710054, PR China
| | - Jianbing Ma
- Hong-Hui Hospital, Xi'an Jiaotong University College of Medicine, 710054, PR China.
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Li J, Li HB, Zhai XC, Qin-lei, Jiang XQ, Zhang ZH. Topical use of topical fibrin sealant can reduce the need for transfusion, total blood loss and the volume of drainage in total knee and hip arthroplasty: A systematic review and meta-analysis of 1489 patients. Int J Surg 2016; 36:127-137. [DOI: 10.1016/j.ijsu.2016.10.022] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2016] [Accepted: 10/15/2016] [Indexed: 10/20/2022]
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Han SB, Kim HJ, Kim TK, In Y, Oh KJ, Koh IJ, Lee DH. Computer navigation is effective in reducing blood loss but has no effect on transfusion requirement following primary total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc 2016; 24:3474-3481. [PMID: 26922056 DOI: 10.1007/s00167-016-4053-x] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/18/2015] [Accepted: 02/09/2016] [Indexed: 11/26/2022]
Abstract
PURPOSE This meta-analysis was designed to evaluate the effects of computer navigation on blood conservation after total knee arthroplasty (TKA) by comparing postoperative blood loss and need for allogenic blood transfusion in patients undergoing computer navigation and conventional primary TKAs. METHODS Studies were included in this meta-analysis if they compared change in haemoglobin concentration before and after surgery, postoperative blood loss via drainage or calculated total blood loss, and/or allogenic blood transfusion rate following TKA using computer navigation and conventional methods. For all comparisons, odds ratios and 95 % confidence intervals (CI) were calculated for binary outcomes, while mean difference and 95 % CI were calculated for continuous outcomes. RESULTS Twelve studies were included in this meta-analysis. The change in haemoglobin concentration was 0.39 g/dl lower with computer navigation than with conventional TKA (P = 0.006). Blood loss via drainage was 83.1 ml (P = 0.03) lower and calculated blood loss was 185.4 ml (P = 0.002) lower with computer navigation than with conventional TKA. However, the need for blood transfusion was similar for the two approaches (n.s.). CONCLUSIONS The primary TKA with computer navigation was effective in reducing haemoglobin loss and blood loss, but had no effect on transfusion requirement, compared with conventional primary TKA. These findings suggest the importance of analysing several blood loss parameters, because each may not always accurately reflect true postsurgical bleeding. LEVEL OF EVIDENCE Meta-analysis, Level III.
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Affiliation(s)
- Seung-Beom Han
- Department of Orthopaedic Surgery, College of Medicine, Anam Hospital, Korea University, Seoul, South Korea
| | - Hyun-Jung Kim
- Department of Preventive Medicine, College of Medicine, Korea University, Seoul, South Korea
| | - Tae-Kyun Kim
- Department of Orthopaedic Surgery, College of Medicine, Seoul National University Bundang Hospital, Seoul National University, Seongnam, South Korea
| | - Yong In
- Department of Orthopaedic Surgery, College of Medicine, Seoul St. Mary's Hospital, Catholic University, Seoul, South Korea
| | - Kwang-Jun Oh
- Department of Orthopaedic Surgery, Konkuk University Hospital, Konkuk University School of Medicine, Seoul, South Korea
| | - In-Jun Koh
- Department of Orthopaedic Surgery, College of Medicine, Seoul St. Mary's Hospital, Catholic University, Seoul, South Korea
| | - Dae-Hee Lee
- Department of Orthopaedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Ilwon-ro, Gangnam-gu, Seoul, 135-710, South Korea.
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Yuan ZF, Yin H, Ma WP, Xing DL. The combined effect of administration of intravenous and topical tranexamic acid on blood loss and transfusion rate in total knee arthroplasty: Combined tranexamic acid for TKA. Bone Joint Res 2016; 5:353-61. [PMID: 27587787 PMCID: PMC5013895 DOI: 10.1302/2046-3758.58.bjr-2016-0001.r2] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/01/2016] [Accepted: 07/14/2016] [Indexed: 11/05/2022] Open
Abstract
OBJECTIVES Tranexamic acid (TXA) is an antifibrinolytic agent used as a blood-sparing technique in total knee arthroplasty (TKA), and is routinely administered by intravenous (IV) or intra-articular (IA) injection. Recently, a novel method of TXA administration, the combined IV and IA application of TXA, has been applied in TKA. However, the scientific evidence of combined administration of TXA in TKA is still meagre. This meta-analysis aimed to investigate the efficacy and safety of combined IV and IA TXA in patients undergoing TKA. MATERIALS AND METHODS A systematic search was carried out in PubMed, the Cochrane Clinical Trial Register (Issue12 2015), Embase, Web of Science and the Chinese Biomedical Database. Only randomised controlled trials (RCT) evaluating the efficacy and safety of combined use TXA in TKA were identified. Two authors independently identified the eligible studies, extracted data and assessed the methodological quality of included studies. Meta-analysis was conducted using Review Manager 5.3 software. RESULTS A total of ten RCTs (1143 patients) were included in this study. All the included studies were randomised and the quality of included studies still needed improvement. The results indicated that, compared with either placebo or the single-dose TXA (IV or IA) group, the combination of IV and IA TXA group had significantly less total blood loss, hidden blood loss, total drain output, a lower transfusion rate and a lower drop in haemoglobin level. There were no statistically significant differences in complications such as wound infection and deep vein thrombosis between the combination group and the placebo or single-dose TXA group. CONCLUSIONS Compared with placebo or the single-dose TXA, the combined use of IV and IA TXA provided significantly better results with respect to all outcomes related to post-operative blood loss without increasing the risk of thromboembolic complications in TKA.Cite this article: Z. F. Yuan, H. Yin, W. P. Ma, D. L. Xing. The combined effect of administration of intravenous and topical tranexamic acid on blood loss and transfusion rate in total knee arthroplasty: combined tranexamic acid for TKA. Bone Joint Res 2016;5:353-361. DOI: 10.1302/2046-3758.58.BJR-2016-0001.R2.
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Affiliation(s)
- Z F Yuan
- Department of Orthopaedics, Liaocheng People's Hospital and Liaocheng Clinical School of Taishan Medical University, No.67 Dongchang Road, Liaocheng, Shandong 252000, China
| | - H Yin
- Department of Orthopaedics, Liaocheng People's Hospital and Liaocheng Clinical School of Taishan Medical University, No.67 Dongchang Road, Liaocheng, Shandong 252000, China
| | - W P Ma
- Department of Orthopaedics, Liaocheng People's Hospital and Liaocheng Clinical School of Taishan Medical University, No.67 Dongchang Road, Liaocheng, Shandong 252000, China
| | - D L Xing
- Department of Orthopaedics, Liaocheng People's Hospital and Liaocheng Clinical School of Taishan Medical University, No.67 Dongchang Road, Liaocheng, Shandong 252000, China
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Gao F, Ma J, Sun W, Guo W, Li Z, Wang W. Topical fibrin sealant versus intravenous tranexamic acid for reducing blood loss following total knee arthroplasty: A systematic review and meta-analysis. Int J Surg 2016; 32:31-7. [DOI: 10.1016/j.ijsu.2016.06.009] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/29/2016] [Revised: 05/13/2016] [Accepted: 06/11/2016] [Indexed: 10/21/2022]
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Aggarwal AK, Singh N, Sudesh P. Topical vs Intravenous Tranexamic Acid in Reducing Blood Loss After Bilateral Total Knee Arthroplasty: A Prospective Study. J Arthroplasty 2016; 31:1442-8. [PMID: 26947543 DOI: 10.1016/j.arth.2015.12.033] [Citation(s) in RCA: 47] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2015] [Revised: 11/25/2015] [Accepted: 12/15/2015] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Total knee arthroplasty (TKA) results in substantial postoperative blood loss with increased morbidity. Despite various studies proving the efficacy of tranexamic acid (TXA), no consensus exists on the routes of administration. METHODS Seventy consecutive patients with knee arthritis undergoing simultaneous bilateral TKA, who were eligible and fulfilled the criteria, were taken up for this study. They were randomly allocated by a computer-generated random number table, either to receive intravenous TXA (IVTXA; group 1) or topical TXA (TTXA; group 2) in a prospective, double-blinded study. The primary outcome measures were total blood loss and total drain output. The secondary outcome measures were number of blood units transfused and clinical and functional outcomes as evaluated by the Knee Society Score, Western Ontario and McMaster Universities Arthritis Index score, visual analog score, and wound score. RESULTS Both groups were similar in age, sex, and body mass index, and no statistical significance was observed. There was statistically significant difference between IVTXA and TTXA groups in mean postoperative total blood loss (P < .001), postoperative hemoglobin (P < .001) with a higher drop of hemoglobin in the former, total drain output (P < .001), and allogeneic blood transfusion (P < .001). No complication was observed in either group. Significant difference was observed in the Western Ontario and McMaster Universities Arthritis Index score at 12 weeks and 6 months (P = .015 and .007) and Knee Society Score at 6 and 12 months (P = .050 and .045, respectively). However, no significant difference was found at 6 weeks. CONCLUSION TTXA is better than IVTXA in reducing blood loss and clinical outcome after simultaneous bilateral TKA.
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Affiliation(s)
- Aditya K Aggarwal
- Department of Orthopaedic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Nagmani Singh
- Department of Orthopaedic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Pebam Sudesh
- Department of Orthopaedic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India
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Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl) 2016; 128:2856-60. [PMID: 26521781 PMCID: PMC4756876 DOI: 10.4103/0366-6999.168041] [Citation(s) in RCA: 93] [Impact Index Per Article: 10.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Abstract
BACKGROUND Currently, various calculation methods for evaluating blood-loss in patients with total knee arthroplasty (TKA) are applied in clinical practice. However, different methods may yield different results. The purpose of this study was to determine the most reliable method for calculating blood-loss after primary TKA. METHODS We compared blood-loss in 245 patients who underwent primary unilateral TKA from February 2010 to August 2011. We calculated blood-loss using four methods: Gross equation, hemoglobin (Hb) balance, the Orthopedic Surgery Transfusion Hemoglobin European Overview (OSTHEO) formula, and Hb-dilution. We determined Pearson's correlation coefficients for the four methods. RESULTS There were large differences in the calculated blood-loss obtained by the four methods. In descending order of combined correlation coefficient based on calculated blood-loss, the methods were Hb-balance, OSTHEO formula, Hb-dilution, and Gross equation. CONCLUSIONS The Hb-balance method may be the most reliable method of estimating blood-loss after TKA.
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Affiliation(s)
| | - Zi-Jian Li
- Department of Orthopedics, Peking University Third Hospital, Beijing 100191, China
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Uso do ácido tranexâmico em artroplastia total primária de joelho: repercussões na perda sanguínea perioperatória. Braz J Anesthesiol 2016; 66:254-8. [DOI: 10.1016/j.bjan.2014.11.002] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2014] [Accepted: 11/04/2014] [Indexed: 11/22/2022] Open
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Estcourt LJ, Desborough M, Brunskill SJ, Doree C, Hopewell S, Murphy MF, Stanworth SJ, Cochrane Haematological Malignancies Group. Antifibrinolytics (lysine analogues) for the prevention of bleeding in people with haematological disorders. Cochrane Database Syst Rev 2016; 3:CD009733. [PMID: 26978005 PMCID: PMC4838155 DOI: 10.1002/14651858.cd009733.pub3] [Citation(s) in RCA: 28] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND People with haematological disorders are frequently at risk of severe or life-threatening bleeding as a result of thrombocytopenia (reduced platelet count). This is despite the routine use of prophylactic platelet transfusions to prevent bleeding once the platelet count falls below a certain threshold. Platelet transfusions are not without risk and adverse events may be life-threatening. A possible adjunct to prophylactic platelet transfusions is the use of antifibrinolytics, specifically the lysine analogues tranexamic acid (TXA) and epsilon aminocaproic acid (EACA). This is an update of a Cochrane review first published in 2013. OBJECTIVES To determine the efficacy and safety of antifibrinolytics (lysine analogues) in preventing bleeding in people with haematological disorders. SEARCH METHODS We searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (The Cochrane Library 2016, Issue 3), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950) and ongoing trial databases to 07 March 2016. SELECTION CRITERIA We included RCTs involving participants with haematological disorders, who would routinely require prophylactic platelet transfusions to prevent bleeding. We only included trials involving the use of the lysine analogues TXA and EACA. DATA COLLECTION AND ANALYSIS Two review authors independently screened all electronically-derived citations and abstracts of papers, identified by the review search strategy, for relevancy. Two review authors independently assessed the full text of all potentially relevant trials for eligibility, completed the data extraction and assessed the studies for risk of bias using The Cochrane Collaboration's 'Risk of bias' tool. We requested missing data from one author but the data were no longer available. The outcomes are reported narratively: we performed no meta-analyses because of the heterogeneity of the available data. MAIN RESULTS We identified three new studies in this update of the review. In total seven studies were eligible for inclusion, three were ongoing RCTs and four were completed studies. The four completed studies were included in the original review and the three ongoing studies were included in this update. We did not identify any RCTs that compared TXA with EACA.Of the four completed studies, one cross-over TXA study (eight participants) was excluded from the outcome analysis because it had very flawed study methodology. Data from the other three studies were all at unclear risk of bias due to lack of reporting of study methodology.Three studies (two TXA (12 to 56 participants), one EACA (18 participants) reported in four articles (published 1983 to 1995) were included in the narrative review. All three studies compared the drug with placebo. All three studies included adults with acute leukaemia receiving chemotherapy. One study (12 participants) only included participants with acute promyelocytic leukaemia. None of the studies included children. One of the three studies reported funding sources and this study was funded by a charity.We are uncertain whether antifibrinolytics reduce the risk of bleeding (three studies; 86 participants; very low-quality evidence). Only one study reported the number of bleeding events per participant and there was no difference in the number of bleeding events seen during induction or consolidation chemotherapy between TXA and placebo (induction; 38 participants; mean difference (MD) 1.70 bleeding events, 95% confidence interval (CI) -0.37 to 3.77: consolidation; 18 participants; MD -1.50 bleeding events, 95% CI -3.25 to 0.25; very low-quality evidence). The two other studies suggested bleeding was reduced in the antifibrinolytic study arm, but this was statistically significant in only one of these two studies.Two studies reported thromboembolism and no events occurred (68 participants, very low-quality evidence).All three studies reported a reduction in platelet transfusion usage (three studies, 86 participants; very low-quality evidence), but this was reported in different ways and no meta-analysis could be performed. No trials reported the number of platelet transfusions per participant. Only one study reported the number of platelet components per participant and there was a reduction in the number of platelet components per participant during consolidation chemotherapy but not during induction chemotherapy (consolidation; 18 participants; MD -5.60 platelet units, 95% CI -9.02 to -2.18: induction; 38 participants, MD -1.00 platelet units, 95% CI -9.11 to 7.11; very low-quality evidence).Only one study reported adverse events of TXA as an outcome measure and none occurred. One study stated side effects of EACA were minimal but no further information was provided (two studies, 74 participants, very low-quality evidence).None of the studies reported on the following pre-specified outcomes: overall mortality, adverse events of transfusion, disseminated intravascular coagulation (DIC) or quality of life (QoL). AUTHORS' CONCLUSIONS Our results indicate that the evidence available for the use of antifibrinolytics in haematology patients is very limited. The trials were too small to assess whether or not antifibrinolytics decrease bleeding. No trials reported the number of platelet transfusions per participant. The trials were too small to assess whether or not antifibrinolytics increased the risk of thromboembolic events or other adverse events. There are three ongoing RCTs (1276 participants) due to be completed in 2017 and 2020.
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Affiliation(s)
- Lise J Estcourt
- NHS Blood and TransplantHaematology/Transfusion MedicineLevel 2, John Radcliffe HospitalHeadingtonOxfordUKOX3 9BQ
| | - Michael Desborough
- NHS Blood and TransplantHaematology/Transfusion MedicineLevel 2, John Radcliffe HospitalHeadingtonOxfordUKOX3 9BQ
| | - Susan J Brunskill
- NHS Blood and TransplantSystematic Review InitiativeLevel 2, John Radcliffe HospitalHeadingtonOxfordOxonUKOX3 9BQ
| | - Carolyn Doree
- NHS Blood and TransplantSystematic Review InitiativeLevel 2, John Radcliffe HospitalHeadingtonOxfordOxonUKOX3 9BQ
| | - Sally Hopewell
- University of OxfordOxford Clinical Trials Research UnitNDORMSWindmill RoadOxfordOxfordshireUKOX3 7LD
| | - Michael F Murphy
- Oxford University Hospitals and the University of OxfordNHS Blood and Transplant; National Institute for Health Research (NIHR) Oxford Biomedical Research CentreJohn Radcliffe HospitalHeadingtonOxfordUK
| | - Simon J Stanworth
- Oxford University Hospitals NHS Foundation Trust and the University of OxfordNational Institute for Health Research (NIHR) Oxford Biomedical Research CentreJohn Radcliffe Hospital, Headley WayHeadingtonOxfordUKOX3 9BQ
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Volquind D, Zardo RA, Winkler BC, Londero BB, Zanelatto N, Leichtweis GP. Use of tranexamic acid in primary total knee replacement: effects on perioperative blood loss. Braz J Anesthesiol 2016; 66:254-8. [PMID: 27108821 DOI: 10.1016/j.bjane.2014.11.004] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2014] [Accepted: 11/04/2014] [Indexed: 10/22/2022] Open
Abstract
BACKGROUND AND OBJECTIVES The use of tranexamic acid in primary total knee replacement surgeries has been the subject of constant study. The strategies to reduce bleeding are aimed at reducing the need for blood transfusion due to the risks involved. In this study we evaluated the use of tranexamic acid in reducing bleeding, need for blood transfusion, and prevalence of postoperative deep vein thrombosis in primary total knee replacement. METHOD 62 patients undergoing primary total knee replacement were enrolled in the study, from June 2012 to May 2013, and randomized to receive a single dose of 2.5g of intravenous tranexamic acid (Group TA) or saline (Group GP), 5min before opening the pneumatic tourniquet, respectively. Hemoglobin, hematocrit, and blood loss were recorded 24h after surgery. Deep vein thrombosis was investigated during patient's hospitalization and 15 and 30 days after surgery in review visits. RESULTS There was no demographic difference between groups. Group TA had 13.89% decreased hematocrit (p=0.925) compared to placebo. Group TA had a decrease of 12.28% (p=0.898) in hemoglobin compared to Group GP. Group TA had a mean decrease of 187.35mL in blood loss (25.32%) compared to group GP (p=0.027). The number of blood transfusions was higher in Group GP (p=0.078). Thromboembolic events were not seen in this study. CONCLUSION Tranexamic acid reduced postoperative bleeding without promoting thromboembolic events.
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Affiliation(s)
- Daniel Volquind
- Unidade de Ensino Médico Propedêutica Anestésico Cirúrgica da Universidade de Caxias do Sul, Caxias do Sul, RS, Brazil; Sociedade Brasileira de Anestesiologia (SBA), Rio de Janeiro, RJ, Brazil; Clínica de Anestesiologia de Caxias do Sul (CAN), Caxias do Sul, RS, Brazil.
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Karaaslan F, Karaoğlu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med 2015; 43:2720-6. [PMID: 26337246 DOI: 10.1177/0363546515599629] [Citation(s) in RCA: 84] [Impact Index Per Article: 8.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Abstract
BACKGROUND A significant proportion of surgeons use intra-articular drains after arthroscopic anterior cruciate ligament (ACL) reconstruction. Hemarthrosis and pain adversely affect the functional outcomes of ACL reconstruction in the early postoperative period. PURPOSE To evaluate the effects of administering tranexamic acid (TXA) to minimize knee joint hemarthrosis and associated pain. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS A total of 105 patients who underwent arthroscopic ACL reconstruction were enrolled in this prospective, randomized, double-blind study. The patients who were randomized to the TXA group (n = 53) received intravenous TXA; the control group (n = 52) did not receive TXA. The anesthetist, surgeon, observer, and patients were blinded to the study groups (double-blinded). TXA was administered as a bolus dose of 15 mg/kg 10 minutes before the inflation of the tourniquet, and an intravenous infusion of 10 mg/kg/h was continued for 3 hours after completion of the operation. In the control group, an equal volume of placebo was administered at the same rate and by the same route. The volume of drained blood was measured 24 hours postoperatively. Pain was evaluated using a visual analog scale (VAS) at a consistent time in the evening of postoperative day 3 and postoperative weeks 2 and 3. The Lysholm knee scoring scale was used to record patient satisfaction and knee function during postoperative weeks 2 and 4. RESULTS Significant differences were observed between the volume of fluid drained (60 mL [TXA group] vs 150 mL [control group]; P < .001) (between-group difference [95% CI], -90 [-114.15 to -65.85]) and hemarthrosis grade in postoperative weeks 1 and 2. In addition, the pain outcome improved in the TXA group after day 3 (VAS score, 1.4) compared with that in the control group (VAS score, 2.9) (P < .001) (95% CI, -1.51 to -0.49). The VAS scores of the TXA group at the end of weeks 2 and 3 were also significantly lower than those in the control group (P < .001) (95% CI, -2.00 to -1.00). The median Lysholm score at the end of week 2 was 70 (range, 40-85) in the control group and 75 (range, 50-90) in the TXA group; at the end of week 4, the score was 75 (range, 50-85) in the control group and 80 (range, 70-85) in the TXA group. A significant difference in the Lysholm score was observed between the 2 groups (P < .001) (95% CIs, 0.08-9.92 and 4.00-10.00 for weeks 2 and 4, respectively). Although range of motion was similar between the groups at the end of week 4, the mean was 107.36° ± 8.36° in the TXA group and 103.65° ± 7.68° in the control group on postoperative day 2 (P = .020) (95% CI, 0.60-6.81). The mean hemarthrosis values at the end of weeks 1 and 2 were significantly lower in the TXA group than in the control group (P < .001), and the need for aspiration in the TXA group during the early postoperative period was significantly lower than in the control group (P < .001). There were no infections in either group, and no patient developed deep venous thrombosis by postoperative day 3. CONCLUSION The results of this prospective, randomized study show that TXA reduced the amount of postoperative hemarthrosis and decreased the need for aspiration of the knee after arthroscopic ACL reconstruction. Consequently, TXA reduced pain and improved range of motion of the knee in the early postoperative period without side effects.
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Affiliation(s)
- Fatih Karaaslan
- Department of Orthopaedics and Traumatology, Bozok University Faculty of Medicine, Yozgat, Turkey
| | - Sinan Karaoğlu
- Department of Orthopaedics and Traumatology, Memorial Kayseri Hospital, Kayseri, Turkey
| | - Emre Yurdakul
- Department of Orthopaedics and Traumatology, Osmaniye State Hospital, Osmaniye, Turkey
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Yu X, Li W, Xu P, Liu J, Qiu Y, Zhu Y. Safety and Efficacy of Tranexamic Acid in Total Knee Arthroplasty. Med Sci Monit 2015; 21:3095-103. [PMID: 26463641 PMCID: PMC4610683 DOI: 10.12659/msm.895801] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Background The prevalence of total knee arthroplasty (TKA) is increasing, which is one of the most frequent operations in orthopedic practice. To further investigate the safe and effective role of using tranexamic acid (TA) in reducing transfusion rate and blood loss in total knee arthroplasty. Material/Methods This meta-analysis was conducted according to the Cochrane methodology. Twenty-eight superior quality and well designed randomized controlled trials (RCT) were collected to analyze for this study. Patients who had undergone primary unilateral TKA were chosen. The software, RevMan 5.2, was used to analyze collected data. Results Finally, 28 RCTs were collected to analyze for this study. Total blood loss was dramatically decreased via the application of TA, by a mean of 420 ml [95% CI: −514 to −327]. A significant reduction about blood transfusion rate was also found in patients who received TA. [RD: −0.26, 95%CI: −0.33 to −0.19]. Moreover, no significant differences were found between TA and control groups in incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE). Conclusions This meta-analysis demonstrates that the application of TA in TKA could decrease total blood loss and transfusion rate. On the other hand, the application of TA is not associated with high incidence of DVT or other adverse events. TA should be taken into account in routine use in primary knee arthroplasty to benefit the patients.
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Affiliation(s)
- Xiao Yu
- Department of Orthopaedics, Shanghai Tenth People's Hospital, Shanghai, China (mainland)
| | - Weili Li
- Department of Orthopaedics, Shanghai Tenth People's Hospital, Shanghai, China (mainland)
| | - Pengchen Xu
- Department of Orthopaedics, Shanghai Tenth People's Hospital, Shanghai, China (mainland)
| | - Jin Liu
- Department of Orthopaedics, Shanghai Tenth People's Hospital, Shanghai, China (mainland)
| | - Yue Qiu
- Department of Orthopaedics, Shanghai Tenth People's Hospital, Shanghai, China (mainland)
| | - Yuchang Zhu
- Department of Orthopaedics, Shanghai Tenth People's Hospital, Shanghai, China (mainland)
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Li ZJ, Fu X, Tian P, Liu WX, Li YM, Zheng YF, Ma XL, Deng WM. Fibrin sealant before wound closure in total knee arthroplasty reduced blood loss: a meta-analysis. Knee Surg Sports Traumatol Arthrosc 2015; 23:2019-25. [PMID: 24525554 DOI: 10.1007/s00167-014-2898-4] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/05/2014] [Accepted: 01/26/2014] [Indexed: 11/29/2022]
Abstract
PURPOSE Fibrin sealant (FS) comprises a mixture of fibrinogen and thrombin that controls bleeding, reduces blood transfusions, improves tissue healing and shortens postoperative recovery time after various surgical procedures. However, no single study has been large enough to definitively determine whether fibrin sealant is safe and effective. We report a meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy and safety of fibrin sealant in total knee arthroplasty. METHODS Articles published before August, 2012 were identified from PubMed, Embase, The Cochrane Library and other internet databases. Relevant journals and the recommendations of expert panels were also searched manually. We included only high-quality RCTs. Two independent reviewers searched and assessed the literature. Relevant data were analysed using RevMan 5.0. RESULTS Seven RCTs met the inclusion criteria. Use of fibrin sealant significantly reduced haemoglobin decline mean difference (MD = -0.72), 95 % confidence interval [95 % CI (-0.83, -0.62), p < 0.00001], postoperative drainage volume [MD = -354.53, 95 % CI (-482.43, -226.63), p < 0.00001], the proportion of patients requiring blood transfusion risk differences [RD = -0.27, 95 % CI (-0.45, -0.08), p = 0.006] and the incidence of wound haematoma [RD = -0.11, 95 % CI (-0.22, -0.00), p = 0.04]. There were no significant differences in deep vein thrombosis, pulmonary embolism, infection rate or other complications between groups. CONCLUSIONS Use of fibrin sealant in total knee arthroplasty was effective and safe, reduced haemoglobin decline, postoperative drainage volume, incidence of haematoma and need for blood transfusion, and did not increase the risk of complications. Due to the limited quality of the evidence currently available, more high-quality RCTs are required. LEVEL OF EVIDENCE II.
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Affiliation(s)
- Zhi-Jun Li
- Department of Orthopedics, Tianjin Medical University General Hospital, Tianjin, 300054, People's Republic of China,
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Wei Z, Liu M. The effectiveness and safety of tranexamic acid in total hip or knee arthroplasty: a meta-analysis of 2720 cases. Transfus Med 2015; 25:151-62. [DOI: 10.1111/tme.12212] [Citation(s) in RCA: 88] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2014] [Revised: 11/30/2014] [Accepted: 05/05/2015] [Indexed: 11/29/2022]
Affiliation(s)
- Z. Wei
- Department of Trauma; Union Medicine Centre of Tianjin; Tianjin China
| | - M. Liu
- Department of Trauma; Union Medicine Centre of Tianjin; Tianjin China
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Kuo SJ, Wang FS, Wang CJ, Ko JY, Chen SH, Siu KK. Effects of Computer Navigation versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels: A Prospective Comparative Study. PLoS One 2015; 10:e0126663. [PMID: 25955252 PMCID: PMC4425488 DOI: 10.1371/journal.pone.0126663] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2014] [Accepted: 04/05/2015] [Indexed: 12/20/2022] Open
Abstract
Total knee arthroplasty (TKA) inevitably perturbs the femoral medullary canal, which increases blood loss or morbidities associated with marrow embolization postoperatively. Computer navigation TKA reportedly minimizes medullary disturbance to alleviate perioperative blood loss. We performed a prospective comparative study, enrolling 87 patients with osteoarthritic knees from March 2011 to December 2011 in our hospital. The patients were separated into two groups, according to the surgeon they visited. Fifty-four patients underwent computer navigation TKAs and 33 had conventional TKAs. Levels of cell adhesion molecules (CAMs), including intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and platelet endothelial cellular adhesion molecule-1 (PECAM-1) in sera and hemovac drainage were measured by ELISA before and 24 hours after the surgery. We showed that patients receiving computer navigation TKAs had less blood loss and lower CAMs in serum and hemovac drainage after the operation. Less postoperative elevation of serum ICAM-1 (p=0.022) and PECAM-1 (p=0.003) from the preoperative baseline after the surgery was also noted. This study provides molecular evidence for the differential extent in vascular injury between conventional and navigation TKAs and sheds light on the possible benefits of computer navigation TKAs.
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Affiliation(s)
- Shu-Jui Kuo
- Department of Orthopedic Surgery, China Medical University Hospital, Taichung, Taiwan
| | - Feng-Sheng Wang
- Department of Medical Research, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Kaohsiung, Taiwan
| | - Ching-Jen Wang
- Department of Medical Research, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Kaohsiung, Taiwan
- Department of Orthopedic Surgery, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Kaohsiung, Taiwan
| | - Jih-Yang Ko
- Department of Medical Research, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Kaohsiung, Taiwan
- Department of Orthopedic Surgery, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Kaohsiung, Taiwan
- * E-mail:
| | - Sung-Hsiung Chen
- Department of Orthopedic Surgery, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Kaohsiung, Taiwan
| | - Ka-Kit Siu
- Department of Orthopedic Surgery, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Kaohsiung, Taiwan
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One step closer to sparing total blood loss and transfusion rate in total knee arthroplasty: a meta-analysis of different methods of tranexamic acid administration. Arch Orthop Trauma Surg 2015; 135:573-88. [PMID: 25739992 DOI: 10.1007/s00402-015-2189-7] [Citation(s) in RCA: 39] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/27/2014] [Indexed: 02/09/2023]
Abstract
BACKGROUND Tranexamic acid (TXA) in orthopedics has recently been gaining favor due to its efficacy and ease of use, both in intravenous (IV) and intraarticular (IA) usage. However, because of safety concerns with IV administration, there has been a growing interest in the IA use of TXA to prevent bleeding. MATERIALS AND METHODS This study conducted a systematic review and meta-analysis that included 31 randomized, controlled trials in which the effect of systemic and topical TXA on total blood loss (TBL), rates of transfusion, and thromboembolic events was investigated. RESULTS Compared to the control, the IA administration of TXA led to the significant reduction of mean TBL (p < 0.001), rate of transfusion (p < 0.001), and reduction of rate of thromboembolic events (p = 0.29). Compared to the control group, the IV administration of TXA resulted in significant reduction of mean TBL (p < 0.001), rate of transfusion (p < 0.001), and rate of thromboembolic events (p = 0.66). Although no significant differences in efficacy and safety between the IA and IV administration of TXA were found, the IA method was safer than the IV method in that it reduced rate of transfusion and thromboembolic events. CONCLUSION This study showed that TXA leads to significant reductions in TBL and the rate of allogeneic transfusions. Generally, no significant difference was detected between IA and IV administration of TXA; however, more studies with focus on safety and efficacy are warranted.
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Is tranexamic acid clinically effective and safe to prevent blood loss in total knee arthroplasty? A meta-analysis of 34 randomized controlled trials. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY 2014; 25:525-41. [DOI: 10.1007/s00590-014-1568-z] [Citation(s) in RCA: 55] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/19/2014] [Accepted: 10/30/2014] [Indexed: 10/24/2022]
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Randelli F, D'Anchise R, Ragone V, Serrao L, Cabitza P, Randelli P. Is the newest fibrin sealant an effective strategy to reduce blood loss after total knee arthroplasty? A randomized controlled study. J Arthroplasty 2014; 29:1516-20. [PMID: 24674732 DOI: 10.1016/j.arth.2014.02.024] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/17/2013] [Revised: 01/07/2014] [Accepted: 02/17/2014] [Indexed: 02/01/2023] Open
Abstract
An RCT was conducted to ascertain whether, compared to control management, topical application of a novel fibrin sealant (Evicel, J&J) in patients undergoing primary TKA reduces peri-operative blood loss. Sixty-two patients were randomized to receive topical application of Evicel (N = 31) or not (N = 31). The mean total blood loss was 1.9L(± 0.7) in the control group and 1.8L(± 0.5) in the treatment group (P = 0.4). The transfusion rate was 32.3% in the control group and 25.8% in the treatment group (P = 0.5). The transfusion rate decreased linearly with increasing preoperative Hb levels in the treatment group (P = 0.005). The results of this study suggest that topical application of this novel fibrin sealant doesn't reduce perioperative blood loss and the need for allogeneic blood transfusion.
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Affiliation(s)
- Filippo Randelli
- IRCCS, Policlinico San Donato, San Donato Milanese, Milan, Italy
| | | | - Vincenza Ragone
- IRCCS, Policlinico San Donato, San Donato Milanese, Milan, Italy
| | - Luca Serrao
- IRCCS, Policlinico San Donato, San Donato Milanese, Milan, Italy
| | - Paolo Cabitza
- IRCCS, Policlinico San Donato, San Donato Milanese, Milan, Italy; Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, Milan, Italy
| | - Pietro Randelli
- IRCCS, Policlinico San Donato, San Donato Milanese, Milan, Italy; Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, Milan, Italy
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Kim TK, Chang CB, Kang YG, Seo ES, Lee JH, Yun JH, Lee SH. Clinical value of tranexamic acid in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc 2014; 22:1870-8. [PMID: 23592025 DOI: 10.1007/s00167-013-2492-1] [Citation(s) in RCA: 52] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2012] [Accepted: 12/04/2012] [Indexed: 12/28/2022]
Abstract
PURPOSE Despite the documented blood-saving effects of tranexamic acid (TNA) in total knee arthroplasty (TKA), the question whether clinical values of TNA are identical in unilateral and bilateral TKAs remains unclear. This study was undertaken to determine the clinical values of TNA in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol in terms of efficacy (total blood loss and transfusion rate) and safety (the incidences of symptomatic deep vein thrombosis and pulmonary embolism). METHODS One hundred and eighty unilateral and 146 bilateral TKA patients were randomized into TNA group or control group. In unilateral TKA patients, TNA (10 mg/kg) was administered intravenously 20 min before tourniquet deflation and repeated 3 h after surgery. In bilateral TKA patients, one more dose (10 mg/kg) was given before tourniquet deflation in the second TKA. A contemporary blood-saving protocol was applied to all patients. The TNA and control groups were compared separately in unilateral and bilateral TKA patients for the efficacy and safety variables. RESULTS In unilateral TKA patients, the TNA group had less total blood loss (905 vs. 1,018 mL, p = 0.018) than the control group, but there was no difference in the allogenic transfusion rate (1 vs. 7 %, n.s.). In bilateral TKA patients, the TNA group showed no differences in total blood loss (1,282 vs. 1,379 mL, n.s.), but a significant reduction in the allogenic transfusion rate (7 vs. 27 %, p = 0.002). No symptomatic deep vein thrombosis or pulmonary embolism was found in all patients. CONCLUSION This study demonstrates that the use of TNA reduces total blood loss, but the effects on the transfusion rate can differ depending on the type of TKAs (unilateral vs. bilateral) and the blood-saving protocols.
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Affiliation(s)
- Tae Kyun Kim
- Joint Reconstruction Center, Seoul National University Bundang Hospital, 166 Gumiro, Bundanggu, Seongnamsi, 463-707, Gyeonggido, Republic of Korea,
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Kim TK, Chang CB, Koh IJ. Practical issues for the use of tranexamic acid in total knee arthroplasty: a systematic review. Knee Surg Sports Traumatol Arthrosc 2014; 22:1849-58. [PMID: 23542923 DOI: 10.1007/s00167-013-2487-y] [Citation(s) in RCA: 67] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2012] [Accepted: 03/22/2013] [Indexed: 10/27/2022]
Abstract
PURPOSE This systematic review was undertaken to answer three specific questions relating to the clinical values of tranexamic acid (TNA) in total knee arthroplasty (TKA): (1) Whether there are differences in blood-saving effects between the systemic and topical administrations; (2) Whether blood-saving effects of TNA differ by doses and timings of administration; and (3) Whether the use of TNA is safe at all reported doses, timings, and routes of administration with respect to the incidences of symptomatic deep-vein thrombosis (DVT) and pulmonary embolism (PE). METHODS A systematic review was carried out with 28 randomised controlled trials to evaluate the efficacy and safety of TNA use in TKA identified from the literature. RESULTS Both systemic and topical administrations reduced blood loss after TKA, but transfusion reducing effects varied in studies whether systemic or topical administrations. The effects of TNA were influenced by doses and timings of administration. No increased incidences of symptomatic DVT and PE were found for all reported doses, timings, and routes of TNA administration. CONCLUSION Surgeons can consider incorporating the use of TNA to their blood-saving protocols in TKA without serious concern of adverse events but need to adopt optimal doses, timings, and routes of TNA administrations.
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Affiliation(s)
- Tae Kyun Kim
- Joint Reconstruction Center, Seoul National University Bundang Hospital, 166 Gumiro, Bundanggu, Seongnamsi, Gyeonggi-do, 463-707, Republic of Korea,
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Saleh A, Hebeish M, Farias-Kovac M, Klika AK, Patel P, Suarez J, Barsoum WK. Use of Hemostatic Agents in Hip and Knee Arthroplasty: A Critical Analysis Review. JBJS Rev 2014; 2:01874474-201401000-00001. [PMID: 27490809 DOI: 10.2106/jbjs.rvw.m.00061] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Affiliation(s)
- Anas Saleh
- Department of Orthopaedic Surgery, Cleveland Clinic, 9500 Euclid Avenue, A41, Cleveland, OH 44195
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Cankaya D, Ozkurt B, Aydin C, Tabak AY. No difference in blood loss between posterior-cruciate-ligament-retaining and posterior-cruciate-ligament-stabilized total knee arthroplasties. Knee Surg Sports Traumatol Arthrosc 2014; 22:1865-9. [PMID: 24384945 PMCID: PMC4104005 DOI: 10.1007/s00167-013-2818-z] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2012] [Accepted: 12/19/2013] [Indexed: 02/06/2023]
Abstract
PURPOSE Posterior-cruciate-ligament-retaining (PCR) and posterior-cruciate-ligament-stabilized (PS) arthroplasties are two major common practices in total knee arthroplasty (TKA). The hypothesis of the present study was that compared with the PCR technique, the PS technique is associated with a higher amount of postoperative blood loss and greater need for blood transfusion in cemented TKA. METHODS In this prospective, randomized study, 100 patients diagnosed with primary knee osteoarthritis were randomly assigned to either the PCR group (Group I) or the PS group (Group II). The exclusion criteria were rheumatological joint disease, previous knee surgery, anticoagulant therapy and hypertension. There were no significant differences in age, body mass index and gender, between the groups. The haemoglobin and haematocrit levels of each patient were recorded preoperatively and on postoperative days 1, 3 and 5. The postoperative suction drainage and blood transfusion volumes were also recorded. RESULTS There were no statistically significant differences in haemoglobin or haematocrit levels between the groups on postoperative days 1, 3 and 5. There were also no statistically significant differences in the total measured blood loss volume, postoperative drainage amounts or transfusion rates between the groups. CONCLUSION Use of the PS technique during cemented TKA does not appear to influence the amount of perioperative blood loss or the need for postoperative blood transfusion in general. The clinical relevance of this study is that the difference in blood loss between the PCR and PS techniques does not need to be considered by surgeons when performing TKA.
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Affiliation(s)
- Deniz Cankaya
- Department of Orthopaedic and Traumatology, Ankara Numune Training and Research Hospital, 06100, Altindag, Ankara, Turkey,
| | - Bulent Ozkurt
- Department of Orthopaedic and Traumatology, Ankara Numune Training and Research Hospital, 06100 Altindag, Ankara Turkey
| | - Cemal Aydin
- Department of Orthopaedic and Traumatology, Ankara Numune Training and Research Hospital, 06100 Altindag, Ankara Turkey
| | - A. Yalcin Tabak
- Department of Orthopaedic and Traumatology, Ankara Numune Training and Research Hospital, 06100 Altindag, Ankara Turkey
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Liu J, Cao JG, Wang L, Ma XL. Effect of fibrin sealant on blood loss following total knee arthroplasty: a systematic review and meta-analysis. Int J Surg 2013; 12:95-102. [PMID: 24316285 DOI: 10.1016/j.ijsu.2013.11.011] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2013] [Revised: 08/29/2013] [Accepted: 11/17/2013] [Indexed: 11/16/2022]
Abstract
OBJECTIVE A systematic review of randomized controlled trials was conducted to examine the efficacy of fibrin sealants for the reduction of postoperative blood loss and allogeneic red blood cell transfusion in total knee arthroplasty (TKA). METHODS Studies published through May 2013 were identified from PubMed, Embase, the Cochrane library, ScienceDirect, and other databases. Two independent reviewers assessed the quality of methodology using the Grade of Recommendations Assessment, Development and Evaluation approach and extracted data from literature. The mean difference (MD) of blood loss, hemoglobin loss, and risk ratios (RR) of transfusion rate and adverse events in the fibrin-treated and placebo groups were pooled throughout the study. The relevant data were analyzed using Stata 11.0 software. RESULTS Eight studies were included in the review, with a total sample size of 558 patients. The drainage blood loss [MD = -354.02 mL, 95% confidence interval (CI) (-500.87 to -207.18); P < 0.05], reduction in calculated total blood loss [MD = -402.12, 95% CI (-599.16 to -205.08); P < 0.05], hemoglobin loss [MD = -0.86 g/dL, 95% CI (-1.10 g/dL to -0.61 g/dL); P < 0.05], and transfusion rate [RR = 0.62, 95% CI (0.45-0.86); P < 0.05] were all significantly reduced following treatment with fibrin sealants. There were no significant differences in the incidence of adverse events [RR = 0.69, 95% CI (0.32-1.59); P > 0.05] among the study groups. CONCLUSIONS The results of the present meta-analysis suggest that fibrin sealants for patients undergoing TKA may reduce blood loss and maintain higher hemoglobin levels, particularly when fibrin sealants are used at higher dosage. Furthermore, fibrin sealants do not increase the risk of postoperative deep vein thrombosis, superficial infection, pulmonary embolism, and hematoma. Further evaluation is required to confirm our findings before fibrin sealants can be used in patients undergoing TKA. LEVEL OF EVIDENCE II.
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Affiliation(s)
- Jun Liu
- Tianjin Union Hospital, Department of Orthopedics, Tianjin 300121, PR China; Tianjin Medical University, Tianjin 30070, PR China
| | | | - Lei Wang
- Tianjin Medical University, Tianjin 30070, PR China
| | - Xin-long Ma
- Department of Orthopedics, General Hospital of Tianjin Medical University, Tianjin 300052, PR China; Department of Orthopedics, Tianjin Hospital, Tianjin 300211, PR China.
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Reinhardt KR, Osoria H, Nam D, Alexiades MA, Figgie MP, Su EP. Reducing blood loss after total knee replacement. Bone Joint J 2013; 95-B:135-9. [DOI: 10.1302/0301-620x.95b11.32904] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
Blood loss during total knee replacement (TKR) remains a significant concern. In this study, 114 patients underwent TKR, and were divided into two groups based on whether they received a new generation fibrin sealant intra-operatively, or a local infiltration containing adrenaline. Groups were then compared for mean calculated total blood volume (TBV) loss, transfusion rates, and knee range of movement. Mean TBV loss was similar between groups: fibrin sealant mean was 705 ml (281 to 1744), local adrenaline mean was 712 ml (261 to 2308) (p = 0.929). Overall, significantly fewer units of blood were transfused in the fibrin sealant group (seven units) compared with the local adrenaline group (15 units) (p = 0.0479). Per patient transfused, significantly fewer units of blood were transfused in the fibrin sealant group (1.0 units) compared with the local adrenaline group (1.67 units) (p = 0.027), suggesting that the fibrin sealant may reduce the need for multiple unit transfusions. Knee range of movement was similar between groups. From our results, it appears that application of this newer fibrin sealant results in blood loss and transfusion rates that are low and similar to previously applied fibrin sealants. Cite this article: Bone Joint J 2013;95-B, Supple A:135–9.
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Affiliation(s)
- K. R. Reinhardt
- NSLIJ Orthopaedic Institute at Southside
Hospital, 301 East Main Street, Bayshore, New
York 11706, USA
| | - H. Osoria
- Weill Cornell Medical College, 1300
York Avenue New York, New York 10021, USA
| | - D. Nam
- Hospital for Special Surgery, 535
East 70th Street, New York, New York, 10021, USA
| | - M. A. Alexiades
- Hospital for Special Surgery, 535
East 70th Street, New York, New York, 10021, USA
| | - M. P. Figgie
- Hospital for Special Surgery, 535
East 70th Street, New York, New York, 10021, USA
| | - E. P. Su
- Hospital for Special Surgery, 535
East 70th Street, New York, New York, 10021, USA
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A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty 2013; 28:78-82. [PMID: 23906869 DOI: 10.1016/j.arth.2013.03.038] [Citation(s) in RCA: 109] [Impact Index Per Article: 9.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/16/2012] [Revised: 03/07/2013] [Accepted: 03/10/2013] [Indexed: 02/01/2023] Open
Abstract
Tranexamic acid (TNA) reduces postoperative blood loss in general and obstetrical surgery but there is limited orthopaedic literature regarding its use in the topical setting. To study the effect of topical TNA after primary total knee arthroplasty (TKA), 101 patients were randomized to topical administration of 2.0g TNA in 75mL of normal saline (50 patients) or placebo (51 patients). Operative technique, drug administration, and venous thromboembolism prophylaxis were standardized. All patients underwent screening ultrasound of the operative extremity. Total blood loss was lower in the TNA group (940.2±327.1mL) than the placebo group (1293.1±532.7mL)(P<0.001), and four patients in the placebo group and none in the TNA group received postoperative transfusion (P=0.118). We recommend administration of topical TNA in primary TKA in healthy patients to decrease perioperative blood loss.
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Wardrop D, Estcourt LJ, Brunskill SJ, Doree C, Trivella M, Stanworth S, Murphy MF. Antifibrinolytics (lysine analogues) for the prevention of bleeding in patients with haematological disorders. Cochrane Database Syst Rev 2013:CD009733. [PMID: 23897323 DOI: 10.1002/14651858.cd009733.pub2] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
Abstract
BACKGROUND Patients with haematological disorders are frequently at risk of severe or life-threatening bleeding as a result of thrombocytopenia. This is despite the routine use of prophylactic platelet transfusions (PlTx) to prevent bleeding once the platelet count falls below a certain threshold. PlTx are not without risk and adverse events may be life-threatening. A possible adjunct to prophylactic PlTxs is the use of antifibrinolytics, specifically the lysine analogues tranexamic acid (TXA) and epsilon aminocaproic acid (EACA). OBJECTIVES To determine the efficacy and safety of antifibrinolytics (lysine analogues) in preventing bleeding in patients with haematological disorders. SEARCH METHODS We searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL Issue 12, 2012), MEDLINE (1948 to 10 January 2013), EMBASE (1980 to 10 January 2013), CINAHL (1982 to 10 January 2013), PubMed (e-publications only) and the Transfusion Evidence Library (1980 to January 2013). We also searched several international and ongoing trial databases to 10 January 2013 and citation-tracked relevant reference lists. SELECTION CRITERIA RCTs involving patients with haematological disorders, who would routinely require prophylactic platelet transfusions to prevent bleeding. We only included trials involving the use of the lysine analogues TXA and EACA. DATA COLLECTION AND ANALYSIS Two authors independently screened all electronically derived citations and abstracts of papers, identified by the review search strategy, for relevancy. Two authors independently assessed the full text of all potentially relevant trials for eligibility, completed the data extraction and assessed the studies for risk of bias using The Cochrane Collaboration's 'Risk of bias' tool. We requested missing data from one author but the data were no longer available. The outcomes are reported narratively: we performed no meta-analyses because of the heterogeneity of the available data. MAIN RESULTS Of 470 articles initially identified, 436 were excluded on the basis of the title and abstract. We reviewed 34 full-text articles from which four studies reported in five articles were eligible for inclusion. We did not identify any RCTs which compared TXA with EACA. We did not identify any ongoing RCTs.One cross-over TXA study (eight patients) was excluded from the outcome analysis because data from this study were at a high risk of bias. Data from the other three studies were all at unclear risk of bias due to lack of reporting of study methodology.Three studies (two TXA (12 to 56 patients), one EACA (18 patients)) reported in four articles (published 1983 to 1995) were included in the narrative review. All three studies compared the drug with placebo.All studies reported bleeding, but it was reported in different ways. All three studies suggested antifibrinolytics reduced the risk of bleeding. The first study showed a difference in average bleeding score of 42 in placebo (P) versus three (TXA). The second study only showed a difference in bleeding episodes during consolidation chemotherapy, with a mean of 2.6 episodes/patient (standard deviation (SD) 2.2) (P) versus a mean of 1.1 episodes/patient (SD 1.4) (TXA). The third study reported bleeding on 50% of days at risk (P) versus bleeding on 31% of days at risk (EACA).Two studies (68 patients) reported thromboembolism and no events occurred.All three studies reported a reduction in PlTx usage. The first study reported a difference of 222 platelet units (P) versus 69 platelet units (TXA). The second study only showed a difference in total platelet usage during consolidation chemotherapy, with a mean of 9.3 units (SD 3.3) (P) versus 3.7 (SD 4.1) (TXA). The third study reported one PlTx every 10.5 days at risk (P) versus one PlTx every 13.3 days at risk (EACA).Two studies reported red cell transfusion requirements and one study found a reduction in red cell transfusion usage.One study reported death due to bleeding as an outcome measure and none occurred.Only one study reported adverse events of TXA as an outcome measure and none occurred.None of the studies reported on the following pre-specified outcomes: overall mortality, adverse events of transfusion, disseminated intravascular coagulation (DIC) or quality of life (QoL). AUTHORS' CONCLUSIONS Our results indicate that the evidence available for the use of antifibrinolytics in haematology patients is very limited. The only available data suggest that TXA and EACA may be useful adjuncts to platelet transfusions so that platelet use, and the complications associated with their use, can be reduced. However, the trials were too small to assess whether antifibrinolytics increased the risk of thromboembolic events. Large, high-quality RCTs are required before antifibrinolytics can be demonstrated to be efficacious and safe in widespread clinical practice.
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Affiliation(s)
- Douglas Wardrop
- Oxford Cancer and Haematology Centre, Haematology, Oxford, UK
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Skovgaard C, Holm B, Troelsen A, Lunn TH, Gaarn-Larsen L, Kehlet H, Husted H. No effect of fibrin sealant on drain output or functional recovery following simultaneous bilateral total knee arthroplasty: a randomized, double-blind, placebo-controlled study. Acta Orthop 2013; 84:153-8. [PMID: 23350579 PMCID: PMC3639335 DOI: 10.3109/17453674.2013.769082] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023] Open
Abstract
BACKGROUND AND PURPOSE Blood loss after total knee arthroplasty (TKA) may lead to anemia, blood transfusions, and increased total costs. Also, bleeding into the periarticular tissue may cause swelling and a reduction in quadriceps strength, thus impairing early functional recovery. In this randomized, double-blind, placebo-controlled study, we analyzed the possible effect of fibrin sealant on blood loss and early functional recovery in a fast-track setting. METHODS 24 consecutive patients undergoing bilateral simultaneous TKA were included. 10 mL of fibrin sealant (Evicel) was sprayed onto one knee whereas the contralateral knee had saline. Drain output, the primary outcome, was measured from knee drains removed exactly 24 h after surgery. Secondary outcomes (knee swelling, pain, strength of knee extension, and range of movement (ROM)) were evaluated up to 21 days after surgery. RESULTS The drain output in knees treated with fibrin sealant and placebo was similar (582 mL and 576 mL, respectively). Likewise, no statistically significant differences were found between groups regarding swelling, pain, strength of knee extension, and ROM. INTERPRETATION Fibrin sealant as a local hemostatic in TKA showed no benefit in reducing drain output or in facilitating early functional recovery when used with a tourniquet, tranexamic acid, and a femoral bone plug.
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Affiliation(s)
- Christian Skovgaard
- Department of Orthopaedic Surgery, Hvidovre Hospital,The Lundbeck Center for Fast-Track Hip and Knee Arthroplasty
| | - Bente Holm
- The Lundbeck Center for Fast-Track Hip and Knee Arthroplasty
| | | | - Troels H Lunn
- The Lundbeck Center for Fast-Track Hip and Knee Arthroplasty,Department of Anaesthesiology, Hvidovre Hospital
| | | | - Henrik Kehlet
- The Lundbeck Center for Fast-Track Hip and Knee Arthroplasty,Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen Denmark
| | - Henrik Husted
- Department of Orthopaedic Surgery, Hvidovre Hospital,The Lundbeck Center for Fast-Track Hip and Knee Arthroplasty
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Ibrahim MS, Khan MA, Nizam I, Haddad FS. Peri-operative interventions producing better functional outcomes and enhanced recovery following total hip and knee arthroplasty: an evidence-based review. BMC Med 2013; 11:37. [PMID: 23406499 PMCID: PMC3606483 DOI: 10.1186/1741-7015-11-37] [Citation(s) in RCA: 130] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/23/2012] [Accepted: 02/13/2013] [Indexed: 01/01/2023] Open
Abstract
The increasing numbers of patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA), combined with the rapidly growing repertoire of surgical techniques and interventions available have put considerable pressure on surgeons and other healthcare professionals to produce excellent results with early functional recovery and short hospital stays. The current economic climate and the restricted healthcare budgets further necessitate brief hospitalization while minimizing costs.Clinical pathways and protocols introduced to achieve these goals include a variety of peri-operative interventions to fulfill patient expectations and achieve the desired outcomes.In this review, we present an evidence-based summary of common interventions available to achieve enhanced recovery, reduce hospital stay, and improve functional outcomes following THA and TKA. It covers pre-operative patient education and nutrition, pre-emptive analgesia, neuromuscular electrical stimulation, pulsed electromagnetic fields, peri-operative rehabilitation, modern wound dressings, standard surgical techniques, minimally invasive surgery, and fast-track arthroplasty units.
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Affiliation(s)
- Mazin S Ibrahim
- Department of Trauma and Orthopaedics, University College Hospital, 235 Euston Road, London, NW1 2BU, UK.
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Di Francesco A, Flamini S, Fiori F, Mastri F. Hemostatic matrix effects on blood loss after total knee arthroplasty: A randomized controlled trial. Indian J Orthop 2013; 47:474-81. [PMID: 24133307 PMCID: PMC3796920 DOI: 10.4103/0019-5413.118203] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
BACKGROUND Total knee arthroplasty (TKA) can result in major postoperative blood loss which can impact on the recovery and rehabilitation of patients. It also requires expensive transfusions. The purpose of the study was to investigate whether a hemostatic matrix, composed of cross-linked gelatin and a thrombin solution, would reduce blood loss in patients following TKA. MATERIALS AND METHODS THIS WAS A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY (TRIAL REGISTRATION: Hospital S. Salvatore L'Aquila ADJ00843) conducted in 93 patients. Criteria for participation were unilateral TKA for osteoarthritis, and a preoperative hemoglobin level >13 g/dL. The outcomes measured were postoperative hemoglobin and hematocrit levels measured at 24h, 72 h, and 7 days. The mean total postoperative blood loss was calculated from drainage volume, patient blood volume, hematocrit, and red blood cell volume. In addition, the drain output within 24 h following surgery and any transfusion requirements were determined. RESULTS Hemostatic matrix-treated patients (n = 51) showed significant reductions in calculated postoperative blood loss of 32.3% and 28.7% versus control in men and women, respectively (P < 0.01). Postoperative blood loss after 24 h in drain was significantly less with the hemostatic matrix versus control, as were decreases in hemoglobin levels 7 days post-surgery (each P < 0.01). Three patients in the control group required blood transfusion, whereas no blood transfusions were necessary in the hemostatic matrix group. CONCLUSION The use of a hemostatic matrix provides a safe and effective means to reduce blood loss and blood transfusion requirements in TKA.
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Affiliation(s)
- Alexander Di Francesco
- Department of Orthopaedic Surgery, San Salvatore Hospital, Via Vetoio, No. 1, 67100 L’Aquila, Italy,Address for correspondence: Dr. Alexander Di Francesco, Via G. Di Vincenzo 23/B, 67100 L’Aquila, Italy. E-mail:
| | - Stefano Flamini
- Department of Orthopaedic Surgery, San Salvatore Hospital, Via Vetoio, No. 1, 67100 L’Aquila, Italy
| | - Filippo Fiori
- Department of Orthopaedic Surgery, San Salvatore Hospital, Via Vetoio, No. 1, 67100 L’Aquila, Italy
| | - Franco Mastri
- Department of Orthopaedic Surgery, San Salvatore Hospital, Via Vetoio, No. 1, 67100 L’Aquila, Italy
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