EUCTR2018-000539-29-NL进行中（未招募）1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) Trial - PeriOperative ISchemic Evaluation-3 (POISE-3) Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are eligible if they fulfill all of the following criteria: 1. =45 years of age; 2. expected to require at least an overnight hospital admission after noncardiac surgery; 3. provide written informed consent to participate in POISE-3; AND 4. have a preoperative NT-pro-BNP measurement =200 ng/L; OR 5. if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill =1 of the following 5 criteria: A. history of coronary artery disease; B. history of peripheral arterial disease; C. history of stroke; D. undergoing major vascular surgery; E. any 3 of the following 9 criteria: undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal, or major orthopedic surgery), history of congestive heart failure, transient ischemic attack, diabetic and currently taking an oral hypoglycemic agent or insulin, age >70 years, hypertension, serum creatinine >175 µmol/L (>2.0 mg/dl), history of smoking within 2 years of surgery, undergoing urgent/emergent surgery.
- •Additionally, patients will be considered eligible for the BP partial factorial if they have been chronically receiving =1 antihypertensive medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7000
排除标准
- •We will exclude patients meeting any of the following criteria:
- •1. Patients undergoing cardiac surgery
- •2. Patients undergoing cranial neurosurgery
- •3. Planned use of systemic TXA during surgery
- •4. Hypersensitivity or known allergy to TXA
- •5. Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
- •6. History of seizure disorder
- •7. Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (<3 months)
- •8. Patients with fibrinolytic conditions following consumption coagulopathy
- •9. Patients with subarachnoid hemorrhage within the past 30 days
- •10. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
- •11. Previously enrolled in POISE-3 Trial
- •Additionally, patients will be excluded for the BP partial factorial if:
- •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
相似试验
进行中（未招募）
1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) TrialEUCTR2018-000539-29-DKHamilton Health Sciences Corporation10,000
进行中（未招募）
1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) TrialThe occurrence of life-threatening, major, and critical organ bleeding, and, major arterial and venous thrombosis in patients undergoing noncardiac surgery. And for patients in the blood pressure management factorial, the occurrence of vascular death and major vascular events.MedDRA version: 20.0Level: LLTClassification code 10043611Term: Thrombosis arterialSystem Organ Class: 100000004866MedDRA version: 21.0Level: LLTClassification code 10043640Term: Thrombosis venousSystem Organ Class: 100000004866MedDRA version: 23.1Level: LLTClassification code 10051014Term: Post procedural bleedingSystem Organ Class: 100000004863EUCTR2018-000539-29-BEHamilton Health Sciences Corporation10,000
进行中（未招募）
1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) TrialThe occurrence of life-threatening, major, and critical organ bleeding, and, major arterial and venous thrombosis in patients undergoing noncardiac surgery. And for patients in the blood pressure management factorial, the occurrence of vascular death and major vascular events.MedDRA version: 20.0Level: LLTClassification code 10043611Term: Thrombosis arterialSystem Organ Class: 100000004866MedDRA version: 21.0Level: LLTClassification code 10043640Term: Thrombosis venousSystem Organ Class: 100000004866MedDRA version: 20.1Level: LLTClassification code 10051014Term: Post procedural bleedingSystem Organ Class: 100000004863EUCTR2018-000539-29-ATHamilton Health Sciences Corporation10,000
已完成
3 期
Peri-Operative ISchemic Evaluation-3 Trialvascular events1001928010023213heart failureNL-OMON48217Population Health Research Institute400
进行中（未招募）
1 期
Evaluation of strategies aiming at controlling perioperative ischemia - 3 (POISE-3)The occurrence of life-threatening, major, and critical organ bleeding in patients who are undergoing noncardiac surgery.MedDRA version: 23.1Level: LLTClassification code 10051014Term: Post procedural bleedingSystem Organ Class: 100000004863EUCTR2018-000539-29-ITHamilton Health Sciences Corporation10,000