CTRI/2019/06/019833招募中3 期
Perioperative ISchemic Evaluation-3 (POISE-3)Trial - POISE-3
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
入选标准
- •Patients need to meet the following criteria for inclusion
- •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 μmol/L ( > 2.0 mg/dl);
- •viii. History of smoking within 2 years of surgery;
- •ix. Undergoing emergent/urgent surgery.
- •INCLUSION CRITERIA SPECIFIC TO PATIENTS IN THE BP MANAGEMENT FACTORIAL COMPONENT OF THE TRIAL
- •For inclusion in the hypotension-avoidance strategy group vs. hypertension-avoidance strategy group, patients are also required to fulfill the following criteria:
- •1.Treated chronically (i.e., at least 30 days in the 6 weeks preceding randomization), with at least one antihypertensive medication of any class (i.e., ACEIs, ARBs, renin inhibitors, β-blockers, calcium channel blockers [CCBs], central α2-agonists, α-blockers, direct vasodilators long-acting nitrates, thiazide diuretics, and potassium sparing diuretics)
- •2. Provide written consent to participate in the partial factorial BP management trial
排除标准
- •We will exclude patients meeting any of the following criteria
- •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 [MDRD])
- •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
- •EXCLUSION CRITERIA SPECIFIC TO PATIENTS IN THE BP MANAGEMENT FACTORIAL COMPONENT OF THE TRIAL
- •Patients meeting any of the following criteria will be excluded:
- •1.Patients with advanced congestive heart failure (New York Heart Association functional class III or IV or left ventricular ejection fraction <=30%),
- •2. Patients with untreated brain aneurysm,
- •3. Patients with previous history of hypertensive related cerebral hemorrhage,
- •4. Patients undergoing surgery for pheochromocytoma or history of untreated
- •pheochromocytoma,
- •5. Patients who are hemodynamically unstable or requiring vasopressors or inotropic support before undergoing surgery.
- •6. Patients with thyrotoxicosis (i.e., severe hyperthyroidism) requiring perioperative beta-blocker therapy.
研究者
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