Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor

April 3, 2026 updated by: Yuming Peng, Beijing Tiantan Hospital

Effect of Perioperative Anti-inflammatory Therapy on Postoperative Stroke in Patients Undergoing Brain Tumor Resection: A Randomized Controlled Trial

Previous studies have shown that the incidence of postoperative stroke, particularly covert stroke, is high following brain tumor resection and is closely associated with inflammatory responses and disruption of the blood-brain barrier. Ulinastatin, a broad-spectrum protease inhibitor, exerts multiple pharmacological effects including anti-inflammatory activity and protection of the blood-brain barrier; however, its efficacy in preventing postoperative stroke has not been validated by prospective studies. Therefore, a single-center, randomized, double-blind, placebo-controlled trial will be conducted, enrolling 1,370 patients undergoing elective supratentorial tumor resection. Patients will receive ulinastatin (6,000 IU/kg) or normal saline both before and after surgery. This study aims to evaluate whether ulinastatin reduces the incidence of postoperative stroke, thereby providing high-level evidence for perioperative brain protection in patients undergoing brain tumor surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I-III
  • Scheduled for elective supratentorial tumor resection
  • Written informed consent provided by the patient or a legally authorized representative

Exclusion Criteria:

  • Known allergy to ulinastatin or any of its excipients
  • Severe preoperative hepatic or renal dysfunction (Child-Pugh class C or estimated glomerular filtration rate < 30 mL/min/1.73 m²)
  • Presence of severe coagulation disorders
  • Severe pre-existing neurological deficits, defined as cognitive impairment based on the Mini-Mental State Examination (MMSE) according to the patient's educational level (illiterate < 17, primary school education < 20, secondary school education or higher < 24), language impairment preventing cooperation with psychiatric assessment, or modified Rankin Scale (mRS) score > 3
  • Pregnancy or breastfeeding
  • Concurrent participation in another clinical trial that may interfere with the results of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
The placebo group patients will be received 0.9% saline intraoperatively.
Drug: 0.9% Saline
An equal volume of 0.9% saline was administered intravenously at the same time points, following the same regimen.
Active Comparator: Ulinastatin group
The ulinastatin group patients will be received ulinastatin intraoperatively.
Drug: Ulinastatin
Ulinastatin at a dose of 6,000 IU/kg was diluted in 100 mL of normal saline and administered intravenously over 30 minutes after anesthesia induction (30 minutes before skin incision) and again immediately after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection.
Time Frame: Evaluation was conducted between postoperative days 3 and 7.
Assessment was performed using cranial magnetic resonance imaging with diffusion-weighted imaging sequences.
Evaluation was conducted between postoperative days 3 and 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Yuming Peng, MD,Ph.D, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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