NCT03505723

PeriOperative ISchemic Evaluation-3 Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,535 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Perioperative Bleeding
• Venous Thrombosis
• Arterial Thrombosis

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous TXA at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.
DRUG	Placebo (Saline)	Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous placebo (0.9% normal saline) at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.
OTHER	Perioperative hypotension-avoidance strategy	Perioperative hypotension-avoidance strategy includes: 1. Preoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg before surgery, 2. Intraoperative blood pressure targeting a mean arterial pressure (MAP) ≥80 mm Hg 3. Postoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg during the first 48 hours after surgery.
OTHER	Perioperative hypertension-avoidance strategy	Perioperative hypertension-avoidance strategy (i.e., routine care) continues all antihypertensive drugs before and after surgery and an intraoperative BP strategy targeting a MAP ≥60 mm Hg.

Timeline

• Start date: 2018-06-27
• Primary completion: 2021-11-08
• Completion: 2023-02-03
• First posted: 2018-04-23
• Last updated: 2025-02-12

Locations

114 sites across 23 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Hong Kong, India, Italy, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Russia, South Africa, Spain, United Kingdom