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

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07520370
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Apr 9, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
1,370 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Ulinastatin group
    The ulinastatin group patients will be received ulinastatin intraoperatively.
  • Placebo Comparator: Placebo group
    The placebo group patients will be received 0.9% saline intraoperatively.

Primary Outcome Measure

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. ]

Central Contacts

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