RecruitingNot ApplicableNCT04754022

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery


Sponsor

Unity Health Toronto

Enrollment

1,440 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • ≥18 and ≤65 years of age
  • Planned cardiac surgery using cardiopulmonary bypass
  • Informed consent obtained
  • Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria5

  • Patients who refuse participation
  • Patients who are unable to receive or who refuse blood products
  • Patients who are involved in a preoperative autologous pre-donation program
  • Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
  • Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

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Interventions

OTHERRestrictive Transfusion Strategy

Patients will receive a RBC transfusion if their Hb concentration is \<75 g/L (\<7.5 g/dL; \<4.7mmol/L) intraoperatively and/or postoperatively.

OTHERLiberal transfusion strategy

Patients will receive a RBC transfusion if their Hb concentration is \<95 g/L (\<9.5 g/dL; \<5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or \<85 g/L (\< 8.5 g/dL; \<5.3mmol/L) on the ward.


Locations(54)

Maine Medical Center

Portland, Maine, United States

The Cooper Health System

Camden, New Jersey, United States

Columbia University

New York, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Royal Adelaide Hospital

Adelaide, Adelaide, Australia

Royal Prince Alfred hospital

Camperdown, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Australia

Alfred Hospital

Prahran, Australia

University of Alberta Hospital

Edmonton, Alberta, Canada

Interior Health Kelowna General Hospital

Kelowna, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Saint John Regional Hospitall

Saint John, New Brunswick, Canada

Health Sciences North Research Institute

Greater Sudbury, Ontario, Canada

Hamilton Health Sciences Centre / Hamilton General Hospital

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Hôpital Sacré-Cœur de Montréal

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

Hospital Universitario San Ignacio

Bogotá, Colombia

Fundacion Abood Shaio

Bogotá, Colombia

Fundacion Cardioinfantil

Bogotá, Colombia

Nasr City Health Insurance Hospital

Naşr, Cairo Governorate, Egypt

Democritus University of Thrace

Alexandroupoli, Evros, Greece

EPIC Hospital

Ahmedabad, Gujarat, India

Windhoek Central Hospital

Windhoek, Khomas Region, Namibia

Shahid Gangalal National Heart Center

Kathmandu, Kathmandu, Nepal

Emergency Institute of Cardiovascular Diseases

Bucharest, Romania, Romania

Saint-Petersburg State University Hospital

Saint Petersburg, Russia

National Heart Centre

Singapore, Singapore

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, South Africa

Hospital de la Santa Creu I Sant Pau

Barcelona, Catalonia, 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, Switzerland

University Hospital Basel

Basel, Switzerland

University Hospital Leicester

Leicester, East Midlands, United Kingdom

Basildon University Hospitals-Mid and South Essex NHS Trust

Basildon, Essex, United Kingdom

University Hospital Southampton Foundation Trust

Southampton, Hampshire, United Kingdom

University Hospitals Sussex NHS Foundation Trust

Brighton, 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, United Kingdom

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