Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ulinastatin, 0.9% Saline.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Stroke, Ulinastatin, Perioperative Anti-inflammatory Therapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Perioperative Anti-inflammatory Therapy on Postoperative Stroke in Patients Undergoing Brain Tumor Resection: A Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07520370 · 20260402