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

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.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Perioperative Anti-inflammatory Therapy Stroke Ulinastatin Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulinastatin

Drug

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.

0.9% saline

Drug

An equal volume of 0.9% saline was administered intravenously at the same time points, following the same regimen.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuming Peng, MD,Ph.D

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Apr 9, 2026
Registry last updated: Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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