Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Nov 6;11(31):7583-7592.
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  1 , Qian Han  1 , Wei Jiao  2 , Li-Kun Yang  1 , Fang Wang  1 , Shan Xue  1 , Meng Shen  1 , Yu-Hai Wang  3
Affiliations
Clinical Trial

Effects of ulinastatin therapy in deep vein thrombosis prevention after brain tumor surgery: A single-center randomized controlled trial

Yun-Na Tao et al. World J Clin Cases. .

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

PubMed Disclaimer

Conflict of interest statement

Conflict-of-interest statement: All authors state that they have no competing interests to disclose.

Figures

Figure 1
Figure 1
Study design. UTI: Ulinastatin; VTE: Venous thromboembolism.
Figure 2
Figure 2
Trial profile. ITT: Intention-to-treat; UTI: Ulinastatin.
Figure 3
Figure 3
The primary endpoint. UTI: Ulinastatin; VTE: Venous thromboembolism.
See this image and copyright information in PMC

References

    1. Wong JM, Panchmatia JR, Ziewacz JE, Bader AM, Dunn IF, Laws ER, Gawande AA. Patterns in neurosurgical adverse events: intracranial neoplasm surgery. Neurosurg Focus. 2012;33:E16. - PubMed
    1. Khorana AA, Vadhan-Raj S, Kuderer NM, Wun T, Liebman H, Soff G, Belani C, O'Reilly EM, McBane R, Eikelboom J, Damaraju CV, Beyers K, Dietrich F, Kakkar AK, Riess H, Peixoto RD, Lyman GH. Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial. Rationale and Design of the CASSINI Trial. Thromb Haemost. 2017;117:2135–2145. - PMC - PubMed
    1. Marras LC, Geerts WH, Perry JR. The risk of venous thromboembolism is increased throughout the course of malignant glioma: an evidence-based review. Cancer. 2000;89:640–646. - PubMed
    1. Dickinson LD, Miller LD, Patel CP, Gupta SK. Enoxaparin increases the incidence of postoperative intracranial hemorrhage when initiated preoperatively for deep venous thrombosis prophylaxis in patients with brain tumors. Neurosurgery. 1998;43:1074–1081. - PubMed
    1. Goldhaber SZ, Dunn K, Gerhard-Herman M, Park JK, Black PM. Low rate of venous thromboembolism after craniotomy for brain tumor using multimodality prophylaxis. Chest. 2002;122:1933–1937. - PubMed

Publication types