PeriOperative ISchemic Evaluation-3 Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Perioperative Bleeding, Venous Thrombosis, Arterial Thrombosis

In brief

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.

Key facts

Study ID

NCT03505723

Run by

Population Health Research Institute

People needed

9535

Starts

2018-06-27

Expected to finish

2023-02-03

Last updated by the study team

2025-02-12

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Undergoing noncardiac surgery;
• ≥ 45 years of age;
• Expected to require at least an overnight hospital admission after surgery;
• Provide written informed consent to participate in the POISE-3 Trial, AND
• 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.

You may not qualify if…

• Patients undergoing cardiac surgery
• Patients undergoing cranial neurosurgery
• Planned use of systemic TXA during surgery
• Low-risk surgical procedure (based on individual physician's judgment)
• Hypersensitivity or known allergy to TXA
• Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
• History of seizure disorder
• Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (<3 month)
• Patients with fibrinolytic conditions following consumption coagulopathy
• Patients with subarachnoid hemorrhage within the past 30 days
• Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
• Previously enrolled in POISE-3 Trial

Where it is running

• Cleveland Clinic, Florida — Weston, Florida, United States
• Columbia University — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest — Winston-Salem, North Carolina, United States
• Cleveland Clinic - Fairview — Cleveland, Ohio, United States
• Cleveland Clinic - Main Campus — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Cleveland Clinic - Hillcrest — Mayfield Heights, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Queen Elizabeth II Jubilee Hospital — Brisbane, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Eastern Health (Box Hill Hospital) — Box Hill, Victoria, Australia
• Dandenong Hospital — Dandenong, Victoria, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• Western Health — Footscray, Australia
• Peter MacCallum Hospital — Melbourne, Australia
• John Hunter Hospital — New Lambton, Australia
• Yale New Haven Hospital — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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