heart failure vascular events
Conditions
Interventions
1. Tranexamic acid or placebo
Within 20 minutes preceding the anticipated skin incision, patients will
receive intravenous TXA or placebo (0.9% normal saline) at a loading dose of 1g
over 10 minutes
Sponsors
Population Health Research Institute
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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.
Exclusion criteria
Exclusion criteria: 1. Planned use of systemic TXA during surgery; 2. Hypersensitivity or known allergy to TXA; 3. Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary efficacy outcome for TXA trial is a composite of life-threatening bleeding, major bleeding, and critical organ bleeding at 30 days after randomization. The co-primary safety outcome for TXA trial is a composite of myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism at 30 days after randomization. The primary outcome for the BP management trial is a composite of vascular death, and non-fatal myocardial infarction, stroke, and cardiac arrest at 30 days after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes for TXA trial are: 1) a net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening, major or critical organ bleeding, myocardial infarction, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism at 30 days after randomization; 2) International Society on Thrombosis and Haemostasis (ISTH) major bleeding; 3) BIMS; 3) MINS; 4) myocardial infarction at 30 days after randomization. The secondary outcomes for the BP management factorial are: 1) all-cause mortality at 30 days after randomization; 2) MINS; 3) myocardial infarction at 30 days after randomization. | — |
Countries
Netherlands
Outcome results
None listed