Overview

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