Recruiting NCT04754022
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Restrictive Transfusion Strategy, Liberal transfusion strategy.
- Who it may be relevant to
- Registry conditions: Disorder, Heart, Postoperative, Cardiac Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Colombia, Egypt +11
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
Overview
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.
Interventions
- Other 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. - Other 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.
Primary outcome measures
- Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke). [Time frame: Within 6 months after cardiac surgery.]
Secondary outcome measures (12)
- Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke). [Time frame: Within 6 months after cardiac surgery.]
- Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke). [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Length of stay in the ICU and hospital. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Prolonged low output state. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Duration of mechanical ventilation. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Incidence of infection. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Acute kidney injury. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Delirium. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Incidence of gut infarction. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Hospital visits. [Time frame: Within 6 months after cardiac surgery.]
- Transfusion requirements. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
- Incidence of seizures. [Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
Eligibility criteria
Inclusion criteria
- ≥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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 15 centers
- University of Alberta Hospital — Edmonton
- Interior Health Kelowna General Hospital — Kelowna
- Vancouver General Hospital — Vancouver
- Saint John Regional Hospitall — Saint John
- Health Sciences North Research Institute — Greater Sudbury
- Hamilton Health Sciences Centre / Hamilton General Hospital — Hamilton
- Kingston Health Sciences Centre — Kingston
- Sunnybrook Health Sciences Center — Toronto
- … and 7 more centers
Australia · 11 centers
- Royal Adelaide Hospital — Adelaide
- Royal Prince Alfred hospital — Camperdown
- Prince of Wales Hospital — Randwick
- Westmead Hospital — Westmead
- Gold Coast University Hospital — Southport
- Flinders Medical Centre — Bedford Park
- Monash Health — Clayton
- St Vincent's Hospital Melbourne — Fitzroy
- … and 3 more centers
United Kingdom · 7 centers
- University Hospital Leicester — Leicester
- Basildon University Hospitals-Mid and South Essex NHS Trust — Basildon
- University Hospital Southampton Foundation Trust — Southampton
- University Hospitals Sussex NHS Foundation Trust — Brighton
- University Hospitals Bristol and Weston NHS Foundation Trust — Bristol
- Royal Papworth Hospital NHS Foundation Trust. — Cambridge
- Manchester University NHS Foundation Trust — Wythenshawe
United States · 4 centers
- Maine Medical Center — Portland
- The Cooper Health System — Camden
- Columbia University — New York
- Thomas Jefferson University — Philadelphia
Colombia · 3 centers
- Hospital Universitario San Ignacio — Bogotá
- Fundacion Abood Shaio — Bogotá
- Fundacion Cardioinfantil — Bogotá
Spain · 3 centers
- Hospital de la Santa Creu I Sant Pau — Barcelona
- Hospital General Universitari de Valencia — Valencia
- Hospital Universitario La Fe Valencia — Valencia
Switzerland · 2 centers
- Inselspital, University Hospital Bern, University of Bern — Bern
- University Hospital Basel — Basel
Egypt · 1 center
- Nasr City Health Insurance Hospital — Naşr
Greece · 1 center
- Democritus University of Thrace — Alexandroupoli
India · 1 center
- EPIC Hospital — Ahmedabad
Namibia · 1 center
- Windhoek Central Hospital — Windhoek
Nepal · 1 center
- Shahid Gangalal National Heart Center — Kathmandu
Romania · 1 center
- Emergency Institute of Cardiovascular Diseases — Bucharest
Russia · 1 center
- Saint-Petersburg State University Hospital — Saint Petersburg
Singapore · 1 center
- National Heart Centre — Singapore
South Africa · 1 center
- Charlotte Maxeke Johannesburg Academic Hospital — Johannesburg
Publications
- 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(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. PMID 41114449
- 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. PMID 34932836
Identifiers
NCT: NCT04754022 · TRICS-IV