Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 6, 2023; 11(31): 7583-7592
Published online Nov 6, 2023. doi: 10.12998/wjcc.v11.i31.7583
Effects of ulinastatin therapy in deep vein thrombosis prevention after brain tumor surgery: A single-center randomized controlled trial
Yun-Na Tao, Qian Han, Wei Jiao, Li-Kun Yang, Fang Wang, Shan Xue, Meng Shen, Yu-Hai Wang
Yun-Na Tao, Qian Han, Li-Kun Yang, Fang Wang, Shan Xue, Meng Shen, Yu-Hai Wang, Department of Neurosurgery, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Wei Jiao, Nursing, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Author contributions: Tao YN, Han Q, Jiao W, and Wang YH were involved in the conception and design of the study; Tao YN, Han Q, Yang LK, Wang F, Xue S, and Shen M were involved in the data analysis; Tao YN, Han Q, Yang LK and Wang YH were involved in the acquisition of data; Tao YN and Shen M contributed substantially to drafting the manuscript and figures; All the authors have read and approved the final manuscript.
Institutional review board statement: The methodology that was used for this study was endorsed by the Clinical Research Ethics Committees of the Wuxi Taihu Hospital of PLA (2019-YXLL-091), and the research was implemented in strict conformity with the guidelines outlined in the Declaration of Helsinki.
Clinical trial registration statement: The registration number for the study was CWXH-IPR-2018004 (date: January 11, 2019).
Informed consent statement: Patients' comprehensive awareness of time, place, and personal, as well as their ability to understand the investigator's explanation, were used to determine whether or not they were competent to give written informed consent.
Conflict-of-interest statement: All authors state that they have no competing interests to disclose.
Data sharing statement: Datasets utilized and/or analyzed during this investigation, including the study protocol, participant data, and statistical analysis plan, which have been redacted, are accessible from the corresponding authors upon valid request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Yu-Hai Wang, MD, PhD, Chief Physician, Doctor, Full Professor, Neurosurgeon, President, Department of Neurosurgery, The 904th Hospital of Joint Logistic Support Force, No. 101 Xing Yuan North Road, Wuxi 214044, Jiangsu Province, China. wangyuhai1516@163.com
Received: August 26, 2023
Peer-review started: August 26, 2023
First decision: October 9, 2023
Revised: October 11, 2023
Accepted: October 23, 2023
Article in press: October 23, 2023
Published online: November 6, 2023
Processing time: 72 Days and 0.2 Hours
Abstract
BACKGROUND

Venous thromboembolism (VTE) is a common neurosurgical complication after brain tumor resection, and its prophylaxis has been widely studied. There are no effective drugs in the clinical management of venous thromboembolism, and there is an absence of evidence-based medicine concerning the treatment of severe multiple traumas.

AIM

To explore whether ulinastatin (UTI) can prevent VTE after brain tumor resection.

METHODS

The present research included patients who underwent brain tumor resection. Patients received UTIs (400,000 IU) or placebos utilizing computer-based random sequencing (in a 1:1 ratio). The primary outcome measures were the incidence of VTE, coagulation function, pulmonary emboli, liver function, renal function, and drug-related adverse effects.

RESULTS

A total of 405 patients were evaluated between January 2019 and December 2021, and 361 of these were initially enrolled in the study to form intention-to-treat, which was given UTI (n = 180) or placebo (n = 181) treatment in a random manner. There were no statistically significant differences in baseline clinical data between the two groups. The incidence of VTE in the UTI group was remarkably improved compared with that in the placebo group. UTI can improve coagulation dysfunction, pulmonary emboli, liver function, and renal function. No significant difference was identified between the two groups in the side effects of UTI-induced diarrhea, vomiting, hospital stays, or hospitalization costs. The incidence of allergies was higher in the UTI group than in the placebo group.

CONCLUSION

The findings from the present research indicated that UTI can decrease the incidence of VTE and clinical outcomes of patients after brain tumor resection and has fewer adverse reactions.

Keywords: Ulinastatin; Venous thromboembolism; Brain tumor resection; Randomized control trial; Outcome

Core Tip: Venous thromboembolism (VTE) is a common neurosurgical complication after brain tumor resection and its prophylaxis has been widely studies, with high morbidity, mortality, increased hospitalizations and higher health care costs. The findings from the present research indicated that ulinastatin can decrease the incidence of VTE and clinical outcomes of patients after brain tumor resection and has fewer adverse reactions.