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NCT04754022NARecruiting

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

Unity Health Toronto

Start Date

11/1/2021

Completion Date

6/1/2026

Summary

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: 1. ≥18 and ≤65 years of age 2. Planned cardiac surgery using cardiopulmonary bypass 3. Informed consent obtained 4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more Exclusion Criteria: 1. Patients who refuse participation 2. Patients who are unable to receive or who refuse blood products 3. Patients who are involved in a preoperative autologous pre-donation program 4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device 5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Interventions

OTHER

Restrictive Transfusion Strategy

OTHER

Liberal transfusion strategy

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Conditions

DisorderHeartPostoperativeCardiac Surgery

Locations

Maine Medical Center

Portland, Maine 04102

United States

The Cooper Health System

Camden, New Jersey 08103

United States

Columbia University

New York, New York 10032

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Royal Adelaide Hospital

Adelaide, Adelaide 5000

Australia

Royal Prince Alfred hospital

Camperdown, New South Wales 2050

Australia

Prince of Wales Hospital

Randwick, New South Wales 2024

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Gold Coast University Hospital

Southport, Queensland 4215

Australia

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

Monash Health

Clayton, Victoria 3168

Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria 3065

Australia

Austin Health

Heidelberg, Victoria 3084

Australia

Royal Melbourne Hospital

Melbourne,

Australia

Alfred Hospital

Prahran, 3181

Australia

University of Alberta Hospital

Edmonton, Alberta T6G 2B7

Canada

Interior Health Kelowna General Hospital

Kelowna, British Columbia V1Y 0C5

Canada

Vancouver General Hospital

Vancouver, British Columbia V5Z 1M9

Canada

Saint John Regional Hospitall

Saint John, New Brunswick E2L 4L2

Canada

Health Sciences North Research Institute

Greater Sudbury, Ontario P3E 5J1

Canada

Hamilton Health Sciences Centre / Hamilton General Hospital

Hamilton, Ontario L8L 2X2

Canada

Kingston Health Sciences Centre

Kingston, Ontario K7L 2V7

Canada

Sunnybrook Health Sciences Center

Toronto, Ontario M4N 3M5

Canada

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario M5B 1W8

Canada

Toronto General Hospital

Toronto, Ontario M5G 2C4

Canada

Montreal Heart Institute

Montreal, Quebec H1T 1C8

Canada

Centre hospitalier de l'Université de Montréal

Montreal, Quebec H2X 0C1

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Hôpital Sacré-Cœur de Montréal

Montreal, Quebec H4J 1C5

Canada

Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL)

Québec, Quebec G1V 4G5

Canada

Hospital Universitario San Ignacio

Bogotá, 110231

Colombia

Fundacion Abood Shaio

Bogotá, 111111

Colombia

Fundacion Cardioinfantil

Bogotá,

Colombia

Nasr City Health Insurance Hospital

Naşr, Cairo Governorate 4450010

Egypt

Democritus University of Thrace

Alexandroupoli, Evros 68100

Greece

EPIC Hospital

Ahmedabad, Gujarat 380060

India

Windhoek Central Hospital

Windhoek, Khomas Region 0000

Namibia

Shahid Gangalal National Heart Center

Kathmandu, Kathmandu 44600

Nepal

Emergency Institute of Cardiovascular Diseases

Bucharest, Romania 022322

Romania

Saint-Petersburg State University Hospital

Saint Petersburg,

Russia

National Heart Centre

Singapore,

Singapore

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng 2196

South Africa

Hospital de la Santa Creu I Sant Pau

Barcelona, Catalonia 08025

Spain

Hospital General Universitari de Valencia

Valencia,

Spain

Hospital Universitario La Fe Valencia

Valencia,

Spain

Inselspital, University Hospital Bern, University of Bern

Bern, Canton of Bern 3010

Switzerland

University Hospital Basel

Basel, 4054

Switzerland

University Hospital Leicester

Leicester, East Midlands LE3 9QP

United Kingdom

Basildon University Hospitals-Mid and South Essex NHS Trust

Basildon, Essex

United Kingdom

University Hospital Southampton Foundation Trust

Southampton, Hampshire SO16 6YD

United Kingdom

University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 1ES

United Kingdom

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol,

United Kingdom

Royal Papworth Hospital NHS Foundation Trust.

Cambridge,

United Kingdom

Manchester University NHS Foundation Trust

Wythenshawe, M23 9QZ

United Kingdom