Transfusion Requirements in Cardiac Surgery III (TRICS III): Study Design of a Randomized Controlled Trial Academic Article uri icon

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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.

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
  • Medicis, Etienne De
  • 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

publication date

  • February 2018