PeriOperative ISchemic Evaluation-3 Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

9,535

Participants

Timeline

Start Date

June 27, 2018

Primary Completion Date

November 8, 2021

Study Completion Date

February 3, 2023

Conditions
Perioperative BleedingVenous ThrombosisArterial 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.

Trial Locations (114)

4108

Queen Elizabeth II Jubilee Hospital, Brisbane

10027

Columbia University, New York

27157

Wake Forest, Winston-Salem

33331

Cleveland Clinic, Florida, Weston

43210

The Ohio State University Wexner Medical Center, Columbus

44111

Cleveland Clinic - Fairview, Cleveland

44124

Cleveland Clinic - Hillcrest, Mayfield Heights

44195

Cleveland Clinic - Main Campus, Cleveland

77030

MD Anderson Cancer Center, Houston

97239

Oregon Health & Science University, Portland

107031

V. Negovskiy Reanimatology Research Institute, Moscow

695011

Government Medical College, Trivandrum

700099

NH Rabindranath Tagore International Inst. of Cardiac Sciences, Kolkata

06510

Yale New Haven Hospital, New Haven

27599-7010

University of North Carolina at Chapel Hill, Chapel Hill

02903

Rhode Island Hospital, Providence

Unknown

Princess Alexandra Hospital, Woolloongabba

Royal Adelaide Hospital, Adelaide

Flinders Medical Centre, Bedford Park

Royal Hobart Hospital, Hobart

Eastern Health (Box Hill Hospital), Box Hill

Dandenong Hospital, Dandenong

Austin Hospital, Heidelberg

Royal Melbourne Hospital, Parkville

Fiona Stanley Hospital, Murdoch

Western Health, Footscray

Peter MacCallum Hospital, Melbourne

John Hunter Hospital, New Lambton

Royal Perth, Perth

Princes of Wales Hospital, Randwick

Goulburn Valley Health, Shepparton

Westmead Hospital, Sydney

Medical University of Vienna, Vienna

CHU Brugmann, Brussels

Cliniques Universitaires Saint-Luc, Brussels

Hospital do Coracao de Pocos de Caldas, Poços de Caldas

Hospital de Clinicas de Porto Alegre, Porto Alegre

University of Calgary, O'Brien Institute for Public Health, Calgary

University of Alberta, Edmonton

Health Sciences Centre, Winnipeg

Kingston Health Sciences Centre, Kingston

University Health Network (Toronto General Hospital), Toronto

CHUM, Montreal

Sherbrooke, Sherbrooke

Royal University Hospital (Saskatoon), Saskatoon

Victoria Hospital, London

Clinica Santa Maria, Santiago

Hospital Hernan Henriquez, Temuco

Second Hospital of Anhui Medical University, Hefei

Shenzhen People's Hospital, Shenzhen

The Fourth Affiliated Hospital of Harbin Medical University, Harbin

West China Hospital of Sichuan University, Chengdu

Bispebjerg Hospital, Copenhagen

Rigshospitalet, Abdominal Centre, Copenhagen

Zealand University Hospital, Køge

Groupe Hospitalier Paris Saint Joseph, Paris

University Hospital RWTH Aachen, Aachen

University Hospital Bonn, Bonn

Klinikum Dortmund gGmbH, Dortmund

University Hospital Düsseldorf, Düsseldorf

Prince of Wales Hospital, Shatin

Surat Institute of Digestive Science, Surat

Sumandeep Vidyapeeth & Dhiraj General Hospital, Vadodara

Nanjappa Hospital, Shimoga

Rahate Surgical Hospital, Nagpur

Sengupta Hospital & Research Institute, Nagpur

AMAI Charitable Trust's Ace Hospital, Pune

Sidhu Hospital Pvt. Ltd., Dorāha

Christian Medical College, Ludhiana, Ludhiana

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Lucknow

TD Medical College, Alappuzha

Bangalore Baptist Hospital, Bangalore

Ospedale Galliera di Genova, Genova

Instituto Clinico San Siro, Milan

IRCCS San Raffaele Scientific Institute, Milan

IRCCS Galeazzi Orthopedic Institute, Milan

Port Dickson Hospital, Port Dickson

Sarawak General Hospital, Kuching

Hospital Kuala Lumpur, Kuala Lumpur

University Malaya Medical Centre, Kuala Lumpur

Hospital Pulau Pinang, Pulau Pinang

Sungai Buloh Hospital, Sungai Buloh

Deventer Ziekenhuis, Deventer

Erasmus University Medical Center, Rotterdam

Auckland General Hospital, Grafton

Middlemore Hospital, Auckland

Waikato District Health Board, Hamilton

Shifa International Hospitals, Islamabad

Aga Khan University, Karachi

Jagiellonian University Medical College, Krakow

Specialistyczny Szpital im. E. Szczeklika w Tarnowie, Tarnów

Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze, Zielona Góra

City Hospital 1 of Arkhangelsk, Arkhangelsk

Moscow Regional Research & Clinical Institute (MONIKI), Moscow

City Hospital N25, Novosibirsk

E. Meshalkin National Medical Research Center, Novosibirsk

Hospital of Saint-Petersburg State University, Saint Petersburg

Tyumen State Medical University, Tyumen

Groote Schuur Hospital, Observatory

Sefako Makgatho Health Sciences University (SMU), Ga-Rankuwa

Steve Biko Academic Hospital - University of Pretoria, Pretoria

Hospital Clinic - Barcelona, Barcelona

Hospital de la Sta Creu i Sant Pau, Barcelona

Hospital Vall D'Hebron, Barcelona

Hospital Dr. Josep Trueta, Girona

Hospital Ramon y Cajal, Madrid

Hospital Universitario Fundacion Alcorcon, Madrid

Hospital Clínico Universitario in Valladolid, Valladolid

Medway NHS Foundation Trust, Gillingham

Chelsea & Westminster Hospital, London

West Middlesex Hospital, London

L8L 2X2

Hamilton General Hospital, Hamilton

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

L8V 1C3

Juravinski Hospital & Cancer Centre, Hamilton

All Listed Sponsors
lead

Population Health Research Institute

OTHER