Brain Tumor, Perioperative Anti-inflammatory Therapy, Stroke, Ulinastatin
Conditions
Brief summary
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
DRUGUlinastatin
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.
DRUG0.9% Saline
An equal volume of 0.9% saline was administered intravenously at the same time points, following the same regimen.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection. | Evaluation was conducted between postoperative days 3 and 7. | Assessment was performed using cranial magnetic resonance imaging with diffusion-weighted imaging sequences. |
Contacts
CONTACTYuming Peng, MD,Ph.D
PRINCIPAL_INVESTIGATORYuming Peng, MD,Ph.D
Beijing Tiantan Hospital
Outcome results
None listed