NCT07520370Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1370 (estimated)
- First submitted
- 3 Apr 2026
- Start date
- Jun 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Stroke
- NCT number
- NCT07520370
What you commit to
- Study type: Interventional
- Planned participants: 1370
- From Jun 2026 to the primary completion date, Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another clinical trial that may interfere with the results of this study
Other illness
- Known allergy to ulinastatin or any of its excipients
- 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
Other
- Severe preoperative hepatic or renal dysfunction (Child-Pugh class C or estimated glomerular filtration rate \< 30 mL/min/1.73 m²)
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.