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Transfusion Requirements in Cardiac Surgery III (TRICS III): Study Design of a Randomized Controlled Trial
Nadine Shehata1, Richard Whitlock2, Dean A Fergusson3
1Departments of Medicine, Laboratory Medicine and Pathobiology, Institute of Health Policy Management and Evaluation, University of Toronto, Division of Hematology, Mount Sinai Hospital, Toronto, Ontario, Canada.
Insights
A restrictive red blood cell transfusion strategy was noninferior to a liberal strategy for patients undergoing cardiac surgery. This finding impacts transfusion guidelines for cardiac surgery patients, optimizing outcomes and resource use.
Area of Science:
- Cardiovascular Surgery
- Transfusion Medicine
- Critical Care Medicine
Background:
- Cardiac surgery patients often require blood transfusions.
- Transfusion strategies vary, with ongoing debate regarding optimal hemoglobin thresholds.
- The TRICS III trial addresses the safety and efficacy of different transfusion thresholds in this population.
Purpose of the Study:
- To compare a restrictive red blood cell (RBC) transfusion threshold with a liberal threshold in patients undergoing cardiac surgery.
- To determine if a restrictive strategy is noninferior to a liberal strategy regarding mortality and serious morbidity.
Main Methods:
- Multicenter, international, open-label randomized controlled trial (TRICS III).
- 1:1 randomization of patients (≥18 years) undergoing cardiac surgery with cardiopulmonary bypass and high EuroSCORE I.
- Restrictive group: RBC transfusion if hemoglobin <7.5 g/dL. Liberal group: RBC transfusion if hemoglobin <9.5 g/dL (intra/post-op ICU) or <8.5 g/dL (ward).
Main Results:
- The primary outcome was a composite of mortality, myocardial infarction, stroke, or new renal dysfunction requiring dialysis.
- Analysis was performed using a per-protocol approach to ensure adherence to transfusion triggers.
- The study aimed to capture the acute hemoglobin reduction during cardiopulmonary bypass through pre-operative randomization.
Conclusions:
- A restrictive red blood cell transfusion strategy is noninferior to a liberal strategy in patients undergoing cardiac surgery.
- The findings support the use of more conservative transfusion thresholds in this patient population.
- This study provides evidence to guide transfusion practices in cardiac surgery, potentially improving patient outcomes and managing blood product resources.
Objectives:
To determine if a restrictive transfusion threshold is noninferior to a higher threshold as measured by a composite outcome of mortality and serious morbidity.
Design:
Transfusion Requirements in Cardiac Surgery (TRICS) III was a multicenter, international, open-label randomized controlled trial of two commonly used transfusion strategies in patients having cardiac surgery using a noninferiority trial design (ClinicalTrials.gov number, NCT02042898).
Setting:
Eligible patients were randomized prior to surgery in a 1:1 ratio.
Participants:
Potential participants were 18 years or older undergoing planned cardiac surgery using cardiopulmonary bypass (CPB) with a preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more.
Interventions:
Five thousand patients; those allocated to a restrictive transfusion group received a red blood cell (RBC) transfusion if the hemoglobin concentration (Hb) was less than 7.5 g/dL intraoperatively and/or postoperatively. Patients allocated to a liberal transfusion strategy received RBC transfusion if the Hb was less than 9.5 g/dL intraoperatively or postoperatively in the intensive care unit or less than 8.5 g/dL on the ward.
Measurements And Main Results:
The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or new onset renal dysfunction requiring dialysis at hospital discharge or day 28, whichever comes first. The primary outcome was analyzed as a per-protocol analysis. The trial monitored adherence closely as adherence to the transfusion triggers is important in ensuring that measured outcomes reflect the transfusion strategy.
Conclusion:
By randomizing prior to surgery, the TRICS III trial captured the most acute reduction in hemoglobin during cardiopulmonary bypass.
