跳至主要内容
临床试验/CTRI/2019/06/019833
CTRI/2019/06/019833
招募中
3 期

Perioperative ISchemic Evaluation-3 (POISE-3)Trial - POISE-3

Population Health Research Institute0 个研究点目标入组 0 人待定

概览

阶段
3 期
干预措施
未指定
疾病 / 适应症
Health Condition 1: I95-I99- Other and unspecified disorders of the circulatory system
发起方
Population Health Research Institute
状态
招募中
最后更新
4年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
4年前
研究类型
Interventional

研究者

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

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

结局指标

主要结局

未指定

相似试验

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
已完成
3 期
Peri-Operative ISchemic Evaluation-3 Trialheart failurevascular events1001928010023213
NL-OMON48217Population Health Research Institute400
进行中(未招募)
1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) Trial
EUCTR2018-000539-29-DKHamilton Health Sciences Corporation10,000
进行中(未招募)
1 期
PeriOperative ISchemic Evaluation-3 (POISE-3) Trial
EUCTR2018-000539-29-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