• J. Cardiothorac. Vasc. Anesth. · Feb 2018

    Randomized Controlled Trial Multicenter Study

    Transfusion Requirements in Cardiac Surgery III (TRICS III): Study Design of a Randomized Controlled Trial.

    • Nadine Shehata, Richard Whitlock, Dean A Fergusson, Kevin E Thorpe, Charlie MacAdams, Hilary P Grocott, Fraser Rubens, Stephen Fremes, Francois Lellouche, Sean Bagshaw, Alistair Royse, Peter M Rosseel, Greg Hare, Etienne De Medicis, Christopher Hudson, Emilie Belley-Cote, Daniel Bainbridge, Blaine Kent, Andrew Shaw, Kelly Byrne, Summer Syed, Colin F Royse, Shay McGuiness, Judith Hall, and C David Mazer.
    • Departments 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.
    • J. Cardiothorac. Vasc. Anesth. 2018 Feb 1; 32 (1): 121-129.

    ObjectivesTo determine if a restrictive transfusion threshold is noninferior to a higher threshold as measured by a composite outcome of mortality and serious morbidity.DesignTransfusion 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).SettingEligible patients were randomized prior to surgery in a 1:1 ratio.ParticipantsPotential 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.InterventionsFive 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 ResultsThe 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.ConclusionBy randomizing prior to surgery, the TRICS III trial captured the most acute reduction in hemoglobin during cardiopulmonary bypass.Copyright © 2018. Published by Elsevier Inc.

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