Scientific Publications Database

Article Title: Transfusion Requirements in Cardiac Surgery III (TRICS III): Study Design of a Randomized Controlled Trial
Authors: Shehata, Nadine; Whitlock, Richard; Fergusson, Dean A.; Thorpe, Kevin E.; MacAdams, Charlie; Grocott, Hilary P.; Rubens, Fraser; Fremes, Stephen; Lellouche, Francois; Bagshaw, Sean; Royse, Alistair; Rosseel, Peter M.; Hare, Greg; De Medicis, Etienne; Hudson, Christopher; Belley-Cote, Emilie; Bainbridge, Daniel; Kent, Blaine; Shaw, Andrew; Byrne, Kelly; Syed, Summer; Royse, Colin F.; McGuiness, Shay; Hall, Judith; Mazer, C. David
Journal: JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA Volume 32 Issue 1
Date of Publication:2018
Abstract:
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. (C) 2018 Published by Elsevier Ltd.