PeriOperative ISchemic Evaluation-3 Trial

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Tranexamic Acid

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:

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 judgment)

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 thrombosis or venous thromboembolism (<3 month)

9. Patients with fibrinolytic conditions following consumption coagulopathy

10. Patients with subarachnoid hemorrhage within the past 30 days

11. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding

12. Previously enrolled in POISE-3 Trial