NCT07520370

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,370 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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.
DRUG	0.9% Saline	An equal volume of 0.9% saline was administered intravenously at the same time points, following the same regimen.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-12-01
• Completion: 2029-12-31
• First posted: 2026-04-09
• Last updated: 2026-04-09