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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulinastatin group | Active Comparator | The ulinastatin group patients will be received ulinastatin intraoperatively. |
|
| Placebo group | Placebo Comparator | The placebo group patients will be received 0.9% saline intraoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulinastatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection. | Assessment was performed using cranial magnetic resonance imaging with diffusion-weighted imaging sequences. | Evaluation was conducted between postoperative days 3 and 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuming Peng, MD,Ph.D | Contact | 8610-59976658 | florapym766@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuming Peng, MD,Ph.D | Beijing Tiantan Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C028665 | urinastatin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 0.9% Saline | Drug | An equal volume of 0.9% saline was administered intravenously at the same time points, following the same regimen. |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |