PeriOperative ISchemic Evaluation-3 Trial

Last updated: February 10, 2025
Sponsor: Population Health Research Institute
Overall Status: Completed

Phase

3

Condition

Peripheral Arterial Occlusive Disease

Blood Clots

Venous Thrombosis

Treatment

Perioperative hypertension-avoidance strategy

Placebo (Saline)

Perioperative hypotension-avoidance strategy

Clinical Study ID

NCT03505723
2018.02.08
  • Ages > 45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Undergoing noncardiac surgery;

  2. ≥ 45 years of age;

  3. Expected to require at least an overnight hospital admission after surgery;

  4. Provide written informed consent to participate in the POISE-3 Trial, AND

  5. Fulfill ≥1 of the following 6 criteria (A-F):

A. NT-proBNP ≥200 ng/L B. History of coronary artery disease C. History of peripheral arterial disease D. History of stroke E. Undergoing major vascular surgery; OR F. Any 3 of 9 risk criteria i. Undergoing major surgery; ii. History of congestive heart failure; iii. History of a transient ischemic attack; iv. Diabetes and currently taking an oral hypoglycemic agent or insulin; v. Age >70 years; vi. History of hypertension; vii. Serum creatinine > 175 µmol/L (> 2.0 mg/dl); viii. History of smoking within 2 years of surgery; ix. Undergoing emergent/urgent surgery.

Exclusion

Exclusion criteria:

  1. Patients undergoing cardiac surgery

  2. Patients undergoing cranial neurosurgery

  3. Planned use of systemic TXA during surgery

  4. Low-risk surgical procedure (based on individual physician's judgment)

  5. Hypersensitivity or known allergy to TXA

  6. Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis

  7. History of seizure disorder

  8. Patients with recent stroke, myocardial infarction, acute arterial thrombosis orvenous thromboembolism (<3 month)

  9. Patients with fibrinolytic conditions following consumption coagulopathy

  10. Patients with subarachnoid hemorrhage within the past 30 days

  11. Women of childbearing potential who are not taking effective contraception, pregnantor breast-feeding

  12. Previously enrolled in POISE-3 Trial

Study Design

Total Participants: 9535
Treatment Group(s): 4
Primary Treatment: Perioperative hypertension-avoidance strategy
Phase: 3
Study Start date:
June 27, 2018
Estimated Completion Date:
February 03, 2023

Study 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.

Connect with a study center

  • Queen Elizabeth II Jubilee Hospital

    Brisbane, Queensland 4108
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania
    Australia

    Site Not Available

  • Eastern Health (Box Hill Hospital)

    Box Hill, Victoria
    Australia

    Site Not Available

  • Dandenong Hospital

    Dandenong, Victoria
    Australia

    Site Not Available

  • Austin Hospital

    Heidelberg, Victoria
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia
    Australia

    Site Not Available

  • Western Health

    Footscray,
    Australia

    Site Not Available

  • Mackay Base Hospital

    Mackay,
    Australia

    Site Not Available

  • Peter MacCallum Hospital

    Melbourne,
    Australia

    Site Not Available

  • John Hunter Hospital

    New Lambton,
    Australia

    Site Not Available

  • Royal Perth

    Perth,
    Australia

    Site Not Available

  • Princes of Wales Hospital

    Randwick,
    Australia

    Site Not Available

  • Redcliffe Hospital

    Redcliffe,
    Australia

    Site Not Available

  • Goulburn Valley Health

    Shepparton,
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney,
    Australia

    Site Not Available

  • Tweed Hospital

    Tweed Heads,
    Australia

    Site Not Available

  • Medical University of Vienna

    Vienna,
    Austria

    Site Not Available

  • CHU Brugmann

    Brussels,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels,
    Belgium

    Site Not Available

  • Vera Cruz Hospital

    Belo Horizonte, Minas Gerais
    Brazil

    Site Not Available

  • Hospital do Coracao de Pocos de Caldas

    Poços De Caldas, Minas Gerais
    Brazil

    Site Not Available

  • Hospital Barra D'Or

    Rio De Janeiro, RJ
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre,
    Brazil

    Site Not Available

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

    Calgary, Alberta
    Canada

    Site Not Available

  • University of Alberta

    Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Health Sciences Centre

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Juravinski Hospital & Cancer Centre

    Hamilton, Ontario L8V 1C3
    Canada

    Site Not Available

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston, Ontario
    Canada

    Site Not Available

  • Trillium Health Partners

    Mississauga, Ontario
    Canada

    Site Not Available

  • University Health Network (Toronto General Hospital)

    Toronto, Ontario
    Canada

    Site Not Available

  • CHUM

    Montreal, Quebec
    Canada

    Site Not Available

  • Sherbrooke

    Sherbrooke, Quebec
    Canada

    Site Not Available

  • Royal University Hospital (Saskatoon)

    Saskatoon, Saskatchewan
    Canada

    Site Not Available

  • Victoria Hospital

    London,
    Canada

    Site Not Available

  • Clinica Santa Maria

    Santiago,
    Chile

    Site Not Available

  • Hospital Hernan Henriquez

    Temuco,
    Chile

    Site Not Available

  • Second Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Wuhan Union Hospital

    Wuhan, Hebei
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henam
    China

    Site Not Available

  • Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University

    Shanghai,
    China

    Site Not Available

  • Bispebjerg Hospital

    Copenhagen, Capital Region
    Denmark

    Site Not Available

  • Rigshospitalet, Abdominal Centre

    Copenhagen,
    Denmark

    Site Not Available

  • Zealand University Hospital

    Køge,
    Denmark

    Site Not Available

  • CHU d'Angers

    Angers,
    France

    Site Not Available

  • CHU de Brest

    Brest,
    France

    Site Not Available

  • Groupe Hospitalier Paris Saint Joseph

    Paris,
    France

    Site Not Available

  • University Hospital RWTH Aachen

    Aachen,
    Germany

    Site Not Available

  • University Hospital Bonn

    Bonn,
    Germany

    Site Not Available

  • Klinikum Dortmund gGmbH

    Dortmund,
    Germany

    Site Not Available

  • University Hospital Düsseldorf

    Düsseldorf,
    Germany

    Site Not Available

  • University Hospital Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Klinikum Oldenburg AÖR

    Oldenburg,
    Germany

    Site Not Available

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Site Not Available

  • Sevenhills Hospital

    Visakhapatnam, Andhra Pradesh
    India

    Site Not Available

  • Surat Institute of Digestive Science

    Surat, Gujarat
    India

    Site Not Available

  • Sumandeep Vidyapeeth & Dhiraj General Hospital

    Vadodara, Gujurat
    India

    Site Not Available

  • Asian Institute of Medical Sciences

    Faridabad, Haryana
    India

    Site Not Available

  • Nanjappa Hospital

    Shimoga, Karnataka
    India

    Site Not Available

  • Government Medical College

    Trivandrum, Kerala 695011
    India

    Site Not Available

  • Rahate Surgical Hospital

    Nagpur, Maharashtra
    India

    Site Not Available

  • Sengupta Hospital & Research Institute

    Nagpur, Maharashtra
    India

    Site Not Available

  • AMAI Charitable Trust's Ace Hospital

    Pune, Maharashtra
    India

    Site Not Available

  • Sidhu Hospital Pvt. Ltd.

    Doraha, Punjab
    India

    Site Not Available

  • Christian Medical College, Ludhiana

    Ludhiana, Punjab
    India

    Site Not Available

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

    Lucknow, Uttar Pradesh
    India

    Site Not Available

  • NH Rabindranath Tagore International Inst. of Cardiac Sciences

    Kolkata, West Bengal 700099
    India

    Site Not Available

  • TD Medical College

    Alappuzha,
    India

    Site Not Available

  • Bangalore Baptist Hospital

    Bangalore,
    India

    Site Not Available

  • Nizam's Institute

    Hyderabad,
    India

    Site Not Available

  • St. John's Medical College Hospital

    Kormangala,
    India

    Site Not Available

  • Beaumont Hospital

    Beaumont, Dublin
    Ireland

    Site Not Available

  • Ospedale di Asti

    Asti,
    Italy

    Site Not Available

  • PO Busto Arsizio

    Busto Arsizio,
    Italy

    Site Not Available

  • Pineta Grande Hospital

    Castel Volturno,
    Italy

    Site Not Available

  • University Magna Graecia Catanzaro

    Catanzaro,
    Italy

    Site Not Available

  • Ospedale Galliera di Genova

    Genova,
    Italy

    Site Not Available

  • Spedali Riuniti Livorno (Ospedale di Livorno)

    Livorno,
    Italy

    Site Not Available

  • IRCCS San Raffaele Scientific Institute

    Milan,
    Italy

    Site Not Available

  • Instituto Clinico San Siro

    Milan,
    Italy

    Site Not Available

  • IRCCS Galeazzi Orthopedic Institute

    Milano,
    Italy

    Site Not Available

  • Ospedale S. Antonio

    Padova,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Parma

    Parma,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa,
    Italy

    Site Not Available

  • Ospedale di Rivoli

    Rivoli,
    Italy

    Site Not Available

  • Ospedale Santo Spirito in Sassia

    Rome,
    Italy

    Site Not Available

  • Humanitas Research Hospital

    Rozzano,
    Italy

    Site Not Available

  • Azienda ULSS 4 Veneto Orientale

    San Donà Di Piave,
    Italy

    Site Not Available

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo,
    Italy

    Site Not Available

  • ASST Vimercate

    Vimercate,
    Italy

    Site Not Available

  • Port Dickson Hospital

    Port Dickson, Negeri Sembilan
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching, Sarawak
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    Pulau Pinang,
    Malaysia

    Site Not Available

  • Sungai Buloh Hospital

    Sungai Buloh,
    Malaysia

    Site Not Available

  • Deventer Ziekenhuis

    Deventer, Overijssel
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • Auckland General Hospital

    Grafton, Auckland
    New Zealand

    Site Not Available

  • Middlemore Hospital

    Auckland,
    New Zealand

    Site Not Available

  • Waikato District Health Board

    Hamilton,
    New Zealand

    Site Not Available

  • Shifa International Hospitals

    Islamabad, Islamabad Capital Territory
    Pakistan

    Site Not Available

  • Aga Khan University

    Karachi,
    Pakistan

    Site Not Available

  • Jagiellonian University Medical College

    Kraków,
    Poland

    Site Not Available

  • Specialistyczny Szpital im. E. Szczeklika w Tarnowie

    Tarnów,
    Poland

    Site Not Available

  • Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze

    Zielona Góra,
    Poland

    Site Not Available

  • University Hospital & Educational Center of Medical University in Lodz

    Łódź,
    Poland

    Site Not Available

  • Institutul Clinic Fundeni, Bucharest

    Bucharest,
    Romania

    Site Not Available

  • University of Medicine and Pharmacy "Gr. T. Popa"

    Iaşi,
    Romania

    Site Not Available

  • City Hospital 1 of Arkhangelsk

    Arkhangelsk,
    Russian Federation

    Site Not Available

  • Moscow Regional Research & Clinical Institute (MONIKI)

    Moscow,
    Russian Federation

    Site Not Available

  • V. Negovskiy Reanimatology Research Institute

    Moscow, 107031
    Russian Federation

    Site Not Available

  • City Hospital N25

    Novosibirsk,
    Russian Federation

    Site Not Available

  • E. Meshalkin National Medical Research Center

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Hospital of Saint-Petersburg State University

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Tyumen State Medical University

    Tyumen,
    Russian Federation

    Site Not Available

  • King Abdulazzi National Guard Medical City

    Jeddah,
    Saudi Arabia

    Site Not Available

  • Groote Schuur Hospital

    Observatory, Cape Town
    South Africa

    Site Not Available

  • Sefako Makgatho Health Sciences University (SMU)

    Ga-Rankuwa, Gauteng
    South Africa

    Site Not Available

  • Steve Biko Academic Hospital - University of Pretoria

    Pretoria, Gauteng
    South Africa

    Site Not Available

  • Inkosi Albert Luthuli Central Hospital

    Durban, KwaZulu-Natal
    South Africa

    Site Not Available

  • King Edward VIII Hospital

    Congella, Kwazulu-Natal
    South Africa

    Site Not Available

  • Grey's Hospital

    Athlone, Pietermaritzburg
    South Africa

    Site Not Available

  • Stellenbosch

    Stellenbosch, Western Cape
    South Africa

    Site Not Available

  • Hospital Clinic - Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital Vall D'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital de la Sta Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital Dr. Josep Trueta

    Girona,
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Alcorcon

    Madrid,
    Spain

    Site Not Available

  • Hospital Clínico Universitario in Valladolid

    Valladolid,
    Spain

    Site Not Available

  • University Hospital Zurich Irchel

    Zürich,
    Switzerland

    Site Not Available

  • Uganda Heart Institute

    Mulago, Kampala
    Uganda

    Site Not Available

  • St. Francis Hospital Nsambya

    Nsambya, Kampala
    Uganda

    Site Not Available

  • Cleveland Clinic Abu Dhabi

    Abu Dhabi,
    United Arab Emirates

    Site Not Available

  • East Kent Hospitals University NHS Foundation Trust

    Ashford,
    United Kingdom

    Site Not Available

  • Sandwell and West Birmingham

    Birmingham,
    United Kingdom

    Site Not Available

  • East Lancashire Hospitals NHS Foundation Trust

    Blackburn,
    United Kingdom

    Site Not Available

  • Dudley Group NHS Foundation Trust

    Dudley,
    United Kingdom

    Site Not Available

  • Medway NHS Foundation Trust

    Gillingham,
    United Kingdom

    Site Not Available

  • Royal Liverpool Trust

    Liverpool,
    United Kingdom

    Site Not Available

  • Chelsea & Westminster Hospital

    London,
    United Kingdom

    Site Not Available

  • West Middlesex Hospital

    London,
    United Kingdom

    Site Not Available

  • Manchester University Foundation Trust

    Manchester,
    United Kingdom

    Site Not Available

  • Milton Keynes University Hospital Foundation Trust

    Milton Keynes,
    United Kingdom

    Site Not Available

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Trust

    Oxford,
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust

    Stoke-on-Trent,
    United Kingdom

    Site Not Available

  • Pinderfields Hospital, Wakefield, The Mid Yorkshire Hospitals NHS Trust

    Wakefield,
    United Kingdom

    Site Not Available

  • York Teaching Hospitals NHS Foundation Trust

    York,
    United Kingdom

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Cleveland Clinic, Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Columbia University

    New York, New York 10027
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14627
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599-7010
    United States

    Site Not Available

  • Wake Forest

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Cleveland Clinic - Fairview

    Cleveland, Ohio 44111
    United States

    Site Not Available

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Cleveland Clinic - Hillcrest

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Allegheny Health Center

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.