Clinical Trials in Canada / NCT04754022
Recruiting
Not applicable
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
NCT04754022 · tracked via the Priya Life Science Canada tracker
Condition(s) studied
DisorderHeartPostoperativeCardiac Surgery
Investigational drug(s) / intervention(s)
Restrictive Transfusion StrategyLiberal transfusion strategy
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.
Study 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
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)
Primary outcome measure(s)
- 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). — Within 6 months after cardiac surgery.
Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).
Trial sites (54)
| Facility | City | Region | Status |
|---|---|---|---|
| Maine Medical Center | Portland | Maine | Recruiting |
| The Cooper Health System | Camden | New Jersey | Recruiting |
| Columbia University | New York | New York | Not Yet Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Active Not Recruiting |
| Royal Adelaide Hospital | Adelaide | Adelaide | Recruiting |
| Royal Prince Alfred hospital | Camperdown | New South Wales | Recruiting |
| Prince of Wales Hospital | Randwick | New South Wales | Recruiting |
| Westmead Hospital | Westmead | New South Wales | Recruiting |
| Gold Coast University Hospital | Southport | Queensland | Recruiting |
| Flinders Medical Centre | Bedford Park | South Australia | Recruiting |
| Monash Health | Clayton | Victoria | Recruiting |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | Recruiting |
| Austin Health | Heidelberg | Victoria | Recruiting |
| Royal Melbourne Hospital | Melbourne | Australia | Recruiting |
| Alfred Hospital | Prahran | Australia | Recruiting |
| University of Alberta Hospital | Edmonton | Alberta | Recruiting |
| Interior Health Kelowna General Hospital | Kelowna | British Columbia | Recruiting |
| Vancouver General Hospital | Vancouver | British Columbia | Recruiting |
| Saint John Regional Hospitall | Saint John | New Brunswick | Recruiting |
| Health Sciences North Research Institute | Greater Sudbury | Ontario | Recruiting |
| Hamilton Health Sciences Centre / Hamilton General Hospital | Hamilton | Ontario | Recruiting |
| Kingston Health Sciences Centre | Kingston | Ontario | Active Not Recruiting |
| Sunnybrook Health Sciences Center | Toronto | Ontario | Recruiting |
| St. Michael's Hospital, Unity Health Toronto | Toronto | Ontario | Recruiting |
| Toronto General Hospital | Toronto | Ontario | Recruiting |
| Montreal Heart Institute | Montreal | Quebec | Recruiting |
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | Recruiting |
| Jewish General Hospital | Montreal | Quebec | Recruiting |
| Hôpital Sacré-Cœur de Montréal | Montreal | Quebec | Recruiting |
| Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL) | Québec | Quebec | Recruiting |
| Hospital Universitario San Ignacio | Bogotá | Colombia | Recruiting |
| Fundacion Abood Shaio | Bogotá | Colombia | Recruiting |
| Fundacion Cardioinfantil | Bogotá | Colombia | Recruiting |
| Nasr City Health Insurance Hospital | Naşr | Cairo Governorate | Active Not Recruiting |
| Democritus University of Thrace | Alexandroupoli | Evros | Recruiting |
| EPIC Hospital | Ahmedabad | Gujarat | Recruiting |
| Windhoek Central Hospital | Windhoek | Khomas Region | Active Not Recruiting |
| Shahid Gangalal National Heart Center | Kathmandu | Kathmandu | Recruiting |
| Emergency Institute of Cardiovascular Diseases | Bucharest | Romania | Recruiting |
| Saint-Petersburg State University Hospital | Saint Petersburg | Russia | Suspended |
+ 14 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04754022 on ClinicalTrials.gov ↗ ← All trials in Canada