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

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.

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