EUCTR2018-000539-29-DK
进行中（未招募）
1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) Trial - PeriOperative ISchemic Evaluation-3 (POISE-3) Trial
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Hamilton Health Sciences Corporation
- 入组人数
- 10000
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
- •Patients will be eligible for inclusion in the cogPOISE\-3 substudy if they are enrolled in both the TXA and blood pressure management arms of the POISE\-3 trial. cogPOISE\-3 patients will be included in the cognitive assessment part of the substudy if they consent to the assessment of their cognitive performance at baseline (i.e., within 30 days prior to randomization) and at 1 year after randomization. Patients with a documented history of dementia will not be eligible for the cognitive assessment part of the substudy.
- •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\. Low\-risk surgical procedure (based on individual physician's
- •5\. Hypersensitivity or known allergy to TXA
- •6\. Creatinine clearance \<30 mL/min (Cockcroft\-Gault equation) or on
- •chronic dialysis
- •7\. History of seizure disorder
- •8\. Patients with recent stroke, myocardial infarction, acute arterial
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) TrialEUCTR2018-000539-29-NLHamilton 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: 100000004863Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-000539-29-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: 100000004863Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-000539-29-ATHamilton Health Sciences Corporation10,000
已完成
3 期
Peri-Operative ISchemic Evaluation-3 Trialheart failurevascular events1001928010023213NL-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: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]EUCTR2018-000539-29-ITHamilton Health Sciences Corporation10,000