Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
NCT ID: NCT04754022
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1440 participants
INTERVENTIONAL
2021-11-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Restrictive 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.
Restrictive 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.
Liberal 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.
Liberal 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.
Interventions
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Restrictive 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.
Liberal 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.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
65 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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David Mazer, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Nadine Shehata, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Robert Kramer, MD
Role: backup
Ludmil Mitrev, MD
Role: backup
Aaron Mittel, MD
Role: backup
Kate Drummond, MD
Role: backup
Paul Bannon, MD
Role: backup
Aine Duggan, MD
Role: backup
Stefan Dieleman, MD
Role: backup
Matthew Beech, MD
Role: backup
Robert Baker
Role: backup
Julian Smith, MD
Role: backup
David Scott, MD
Role: backup
Raymond Hu, MD
Role: backup
Alistair Royse, MD
Role: backup
Paul Myles, MD
Role: backup
Wing Lam, MD
Role: backup
Nick Kuzak
Role: backup
Darren Mullane, MD
Role: backup
Craig Brown
Role: backup
Eugene Leshchyshyn, MD
Role: backup
Richard Whitlock
Role: backup
Stephen Fremes, MD
Role: backup
David Mazer, MD
Role: backup
Matteo Parotto, MD
Role: backup
Antoine Rochon, MD
Role: backup
François Carrier
Role: backup
Matthew Cameron, MD
Role: backup
Hugues Jeanmart, MD
Role: backup
Étienne J Couture
Role: backup
Edgar Rios, MD
Role: backup
Mauricio Abello Sanchez, MD
Role: backup
Edgar Leiva, MD
Role: backup
Dimos Karangelis, MD
Role: backup
Chirag Mehta, MD
Role: backup
Ashish Amatya, MD
Role: backup
Daniela Filipescu, MD
Role: backup
Hwang Chih, MD
Role: backup
Ana Maria Gomez Caro, MD
Role: backup
Joaquin Moreno-Pachon, MD
Role: backup
Paula Carmona Garcia, MD
Role: backup
Gabor Erdoes, MD
Role: backup
Daniel Bolliger, MD
Role: backup
Gavin Murphy, MD
Role: backup
Kunal Waghmare, MD
Role: backup
Paul Diprose, MD
Role: backup
Michael Lewis, MD
Role: backup
Ben Gibbison, MD
Role: backup
Andrew klein, MD
Role: backup
Seema Agarwal, MD
Role: backup
References
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Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10:CD002042. doi: 10.1002/14651858.CD002042.pub6.
Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
Other Identifiers
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TRICS-IV
Identifier Type: -
Identifier Source: org_study_id
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