NL-OMON48217已完成3 期
Peri-Operative ISchemic Evaluation-3 Trial - POISE-3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Undergoing noncardiac surgery;
- •2. * 45 years of age;
- •3. Expected to require at least an overnight hospital admission after surgery;
- •4. Provide written informed consent to participate in the POISE-3 Trial, AND
- •5. Fulfill *1 of the following 6 criteria (A-F):
- •A. NT-proBNP *200 ng/L
- •B. History of coronary artery disease
- •C. History of peripheral arterial disease
- •D. History of stroke
- •E. Undergoing major vascular surgery; OR
- •F. Any 3 of 9 risk criteria
- •i. Undergoing major surgery;
- •ii. History of congestive heart failure;
- •iii. History of a transient ischemic attack;
- •iv. Diabetes and currently taking an oral hypoglycemic agent or insulin;
- •v. Age >70 years;
- •vi. History of hypertension;
- •vii. Serum creatinine > 175 *mol/L (> 2.0 mg/dl);
- •viii. History of smoking within 2 years of surgery;
- •ix. Undergoing emergent/urgent surgery.
排除标准
- •1. Planned use of systemic TXA during surgery;
- •2. Hypersensitivity or known allergy to TXA;
- •3. Creatinine clearance <30 mL/min (Modification of Diet in Renal Disease
- •4. History of seizure disorder;
- •5. Patients with recent stroke, myocardial infarction, acute arterial
- •thrombosis or venous thromboembolism (<1 month);
- •6. Patients with subarachnoid hemorrhage within the past 30 days;
- •7. Patients undergoing cranial neurosurgery;
- •8. Previously enrolled in POISE-3 Trial.
研究者
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