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.
Key Words
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Article Info
Publication History
Published online: December 19, 2017
Footnotes
The study was supported by the Canadian Institutes of Health Research, Canadian Blood Services, the National Health and Medical Research Council of Australia, and the Health Research Council of New Zealand. Nadine Shehata is supported by the Canadian Blood Services/Canadian Institute of Health Research New Investigator Award. C. David Mazer is supported by a Merit Award from the Department of Anesthesia, St. Michael’s Hospital, University of Toronto
Identification
Copyright
© 2017 Published by Elsevier Inc.
