NL-OMON48217
Completed
Phase 3
Peri-Operative ISchemic Evaluation-3 Trial - POISE-3
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- heart failure
- Sponsor
- Population Health Research Institute
- Enrollment
- 400
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion 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
- •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.
Outcomes
Primary Outcomes
Not specified
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