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

NCT07520370 | Not Yet Recruiting

• 1 other identifier: 20260402
• Study Type: interventional
• Target: 1,370
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke; Brain Tumor; Perioperative Anti-inflammatory Therapy; Ulinastatin

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection.

  Assessment was performed using cranial magnetic resonance imaging with diffusion-weighted imaging sequences.

  Evaluation was conducted between postoperative days 3 and 7.

Study Arms (2)

Ulinastatin group

ACTIVE COMPARATOR

The ulinastatin group patients will be received ulinastatin intraoperatively.

Drug: Ulinastatin

Placebo group

PLACEBO COMPARATOR

The placebo group patients will be received 0.9% saline intraoperatively.

Drug: 0.9% Saline

Interventions

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.

Ulinastatin group

0.9% Saline DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Brain Neoplasms; Stroke

Interventions

urinastatin; Saline Solution

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng, MD,Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share