Projects

Project Description

Brief 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.

Official Title

PeriOperative ISchemic Evaluation-3 Trial

Conditions

Perioperative BleedingVenous ThrombosisArterial Thrombosis

Intervention / Treatment

• Drug: Tranexamic Acid
• Drug: Placebo (Saline)
• Other: Perioperative hypotension-avoidance strategy
• Other: Perioperative hypertension-avoidance strategy