PeriOperative ISchemic Evaluation-3 Trial

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.

Conditions

• Perioperative Bleeding
• Venous Thrombosis
• Arterial Thrombosis

Interventions

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.

Sponsors & Collaborators

• Population Health Research Institute

  lead OTHER

Principal Investigators

• PJ Devereaux, MD, PhD · Hamilton Health Sciences Corporation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-06-27

Primary Completion

2021-11-08

Completion

2023-02-03

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

Study Locations