An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
Unity Health Toronto
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 pregnan…
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 CenterPortland, Maine
- The Cooper Health SystemCamden, New Jersey
- Columbia UniversityNew York, New York
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania
- Royal Adelaide HospitalAdelaide, Adelaide
- Royal Prince Alfred hospitalCamperdown, New South Wales