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
ARTICLE HIGHLIGHTS
Research background

Venous thromboembolism (VTE) is a frequently occurring complication following a neurosurgical procedure for the resection of brain tumors, and its prophylaxis has been widely studied, and deep vein thrombosis (DVT) following brain tumor removal may be caused by multiple variables. Furthermore, drugs that effectively prevent DVT without elevating the risk of intracranial hemorrhage are currently unavailable.

Research motivation

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. Previous study showed that ulinastatin (UTI) may help alleviate postsurgical hemorrhage and enhance platelet recovery without adding a considerable extra financial burden to patients.

Research objectives

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

Research methods

We conducted a randomized experiment, 405 patients were subjected to the screening process, and of them, 361 were originally recruited in the trial to establish the intention to treat group. Patients received UTIs (400000 IU) or placebos utilizing computer-based random sequencing (in a 1:1 ratio). Then to explore the incidence of VTE, coagulation function, pulmonary emboli, liver function, renal function, and drug-related adverse effects.

Research results

The present study suggests that the risk of VTE is significantly reduced by UTI treatment among patients undergoing brain tumor surgery. We also discovered that UTI is associated with enhanced hepatic and kidney function as well as improved coagulation dysfunction. UTI use does not increase the risk of serious complications, and the increased risk of allergies may be related to the combination of drugs. All patients had mild symptoms and eventually recovered. Furthermore, hospitalization costs were not increased by UTI treatment.

Research conclusions

UTI treatment after brain tumor resection can lower the incidence of VTE, attenuate hyperinflammation, alleviate coagulation dysfunction, and improve liver and kidney functions. Additionally, it lowered the cost during hospital stays significantly.

Research perspectives

Additional research is needed with patients receiving varying doses of UTI to fully understand its potential applicability in patients with multiple traumas.