PeriOperative ISchemic Evaluation-3 Trial

The POISE-3 study is a 10,000 patient, multicentre, international, non-inferiority randomized
controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial
design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy. The
primary objective of the study is to determine; if TXA is superior to placebo for the
occurrence of life-threatening, major, and critical organ bleeding, and non-inferior to
placebo for the occurrence of major arterial and venous thrombotic event; and to determine
the impact of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on
the risk of vascular death and major vascular events in patients who are followed for 30 days
after noncardiac surgery.

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. 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