Abstract

JAMA Transfusion Requirements After Cardiac Surgery: the TRACS Randomized Controlled Trial Ludhmila A. Hajjar, MD, PhD; Jean-Louis Vincent, MD, PhD; Filomena R. B. G. Galas, MD, PhD; Rosana E. Nakamura, MD; Carolina M. P. Silva, MD; Marilia H. Santos, MD, PhD; Julia Fukushima, MSc; Roberto Kalil Filho, MD, PhD; Denise B. Sierra, MD; Neuza H. Lopes, MD, PhD; Thais Mauad, MD, PhD; Aretusa C. Roquim, MD; Marcia R. Sundin, MD; Wanderson C. Leao, MD; Juliano P. Almeida, MD; Pablo M. Pomerantzeff, MD, PhD; Luis O. Dallan, MD, PhD; Fabio B. Jatene, MD, PhD; Noedir A. G. Stolf, MD, PhD; Jose O. C. Auler Jr, MD, PhD Context: Perioperative red blood cell transfusion is commonly used to address anemia, an independent risk factor for morbidity and mortality after cardiac operations; however, evidence regarding optimal blood transfusion practice in patients undergoing cardiac surgery is lacking. Objective: To define whether a restrictive perioperative red blood cell transfusion strategy is as safe as a liberal strategy in patients undergoing elective cardiac surgery. Design, Setting, and Patients: The Transfusion Requirements After Cardiac Surgery (TRACS) study, a prospective, randomized, controlled clinical noninferiority trial conducted between February 2009 and February 2010 in an intensive care unit at a university hospital cardiac surgery referral center in Brazil. Consecutive adult patients (n = 502) who underwent cardiac surgery with cardiopulmonary bypass were eligible; analysis was by intention-to-treat. Intervention: Patients were randomly assigned to a liberal strategy of blood transfusion (to maintain a hematocrit ≥30%) or to a restrictive strategy (hematocrit ≥24%). Main Outcome Measure: Composite end point of 30-day all-cause mortality and severe morbidity (cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration) occurring during the hospital stay. The noninferiority margin was predefined at −8% (ie, 8% minimal clinically important increase in occurrence of the composite end point). Results: Hemoglobin concentrations were maintained at a mean of 10.5 g/dL (95% confidence interval [CI], 10.4-10.6) in the liberal-strategy group and 9.1 g/dL (95% CI, 9.0-9.2) in the restrictive-strategy group (P Conclusion: Among patients undergoing cardiac surgery, the use of a restrictive perioperative transfusion strategy compared with a more liberal strategy resulted in noninferior rates of the combined outcome of 30-day all-cause mortality and severe morbidity. Trial Registration: clinicaltrials.gov Identifier:NCT01021631 doi:10.1001/jama.2010.1446

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