PeriOperative ISchemic Evaluation-3 Trial

Phase 3

Completed

• Conditions: Perioperative Bleeding; Venous Thrombosis; Arterial Thrombosis
• Interventions: Drug: Placebo (Saline); Other: Perioperative hypotension-avoidance strategy; Other: Perioperative hypertension-avoidance strategy; Drug: Tranexamic Acid

• Registration Number: NCT03505723
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-23
• Study Start: 2018-06-27
• Primary Completion: 2021-11-08
• Study Completion: 2023-02-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9535

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo (0.9% normal saline)	Placebo (Saline)	Patients will receive a 1g loading dose of placebo (0.9% normal saline) before surgery and a 1g loading dose of placebo (0.9% normal saline) at the end of surgery (wound closure).
Hypotension-avoidance strategy	Perioperative hypotension-avoidance strategy	Aims to avoid hypotension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).
Perioperative hypertension-avoidance strategy	Perioperative hypertension-avoidance strategy	Aims to avoid hypertension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).
Tranexamic Acid (TXA)	Tranexamic Acid	Patients will receive a 1g loading dose of intravenous TXA before surgery and a 1g loading dose of intravenous TXA at the end of surgery (wound closure).

Primary Outcome Measures

Name	Time	Method
A composite of life-threatening bleeding, major bleeding, and critical organ bleeding	30 days after randomization	Number of patients who have at least one of the following: life-threatening bleeding, major bleeding, and critical organ bleeding
A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.	30 days after randomization	Number of patients who have at least one of the following: myocardial injury after noncardiac surgery, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest.	30 days after randomization	Number of patients enrolled in the blood pressure management arm who have at least one of the following: vascular death, non-fatal myocardial injury after noncardiac surgery, non-fatal stroke, and non-fatal cardiac arrest.

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	30 days after randomization	Number of patients who experience a myocardial infarction
A net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening,major or critical organ bleeding,MINS,stroke,peripheral arterial thrombosis,and symptomatic proximal venous thromboembolism	30 days after randomization	Number of patients who have at least one of the following: vascular death, and non-fatal life-threatening, major or critical organ bleeding, myocardial injury after noncardiac surgery, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism,
BIMS	30 days after randomization	Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS)
MINS	30 days after randomization	Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
MINS not fulfilling the universal definition of myocardial infarction	30 days after randomization	Number of patients who experience a myocardial injury after noncardiac surgery (MINS) not fulfilling the 3rd universal definition of myocardial infarction
For patients in the blood pressure management arm: all-cause mortality	30 days after randomization	Number of patients who die of any cause
For patients in the blood pressure management arm: MINS	30 days after randomization	Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
For patients in the blood pressure management arm: Myocardial infarction	30 days after randomization	Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: MINS not fulfilling the universal definition of myocardial infarction	30 days after randomization	Number of patients who experience MINS not fulfilling the universal definition of myocardial infarction

Trial Locations

Locations (114)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

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

Scroll for more (104 remaining)