Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Perioperative Anti-inflammatory Therapy | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Ulinastatin | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% Saline | Drug | — | UNRESOLVED |
| Ulinastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ulinastatin group
- description
- The ulinastatin group patients will be received ulinastatin intraoperatively.
- interventionNames
- Drug: Ulinastatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- The placebo group patients will be received 0.9% saline intraoperatively.
- interventionNames
- Drug: 0.9% Saline
Primary outcomes (1)
- measure
- Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
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