临床时讯 ＞ 临床研究
JAMA. 2010 Oct 13;304(14):1559-67.
Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial.
Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr.
Surgical Intensive Care Unit and Department of Anesthesiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
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 < .001). A total of 198 of 253 patients (78%) in the liberal-strategy group and 118 of 249 (47%) in the restrictive-strategy group received a blood transfusion (P < .001). Occurrence of the primary end point was similar between groups (10% liberal vs 11% restrictive; between-group difference, 1% [95% CI, -6% to 4%]; P = .85). Independent of transfusion strategy, the number of transfused red blood cell units was an independent risk factor for clinical complications or death at 30 days (hazard ratio for each additional unit transfused, 1.2 [95% CI, 1.1-1.4]; P = .002).
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.
JAMA. 2010 Oct 13;304(14):1568-75.
Variation in use of blood transfusion in coronary artery bypass graft surgery.
Bennett-Guerrero E, Zhao Y, O'Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK.
Division of Perioperative Clinical Research, Duke Clinical Research Institute, Duke University Medical Center, PO Box 3094, Durham, NC 27710, USA.
CONTEXT: Perioperative blood transfusions are costly and have safety concerns. As a result, there have been multiple initiatives to reduce transfusion use. However, the degree to which perioperative transfusion rates vary among hospitals is unknown.
OBJECTIVE: To assess hospital-level variation in use of allogeneic red blood cell (RBC), fresh-frozen plasma, and platelet transfusions in patients undergoing coronary artery bypass graft (CABG) surgery.
DESIGN, SETTING, AND PATIENTS: An observational cohort of 102,470 patients undergoing primary isolated CABG surgery with cardiopulmonary bypass during calendar year 2008 at 798 sites in the United States, contributing data to the Society of Thoracic Surgeons Adult Cardiac Surgery Database.
MAIN OUTCOME MEASURES: Perioperative (intraoperative and postoperative) transfusion of RBCs, fresh-frozen plasma, and platelets.
RESULTS: At hospitals performing at least 100 on-pump CABG operations (82,446 cases at 408 sites), the rates of blood transfusion ranged from 7.8% to 92.8% for RBCs, 0% to 97.5% for fresh-frozen plasma, and 0.4% to 90.4% for platelets. Multivariable analysis including data from all 798 sites (102,470 cases) revealed that after adjustment for patient-level risk factors, hospital transfusion rates varied by geographic location (P = .007), academic status (P = .03), and hospital volume (P < .001). However, these 3 hospital characteristics combined only explained 11.1% of the variation in hospital risk-adjusted RBC usage. Case mix explained 20.1% of the variation between hospitals in RBC usage.
CONCLUSION: Wide variability occurred in the rates of transfusion of RBCs and other blood products, independent of case mix, among patients undergoing CABG surgery with cardiopulmonary bypass in US hospitals in an adult cardiac surgical database.
JAMA. 2010 Oct 13;304(14):1610-1.
Blood transfusion as a quality indicator in cardiac surgery.
Shander AS, Goodnough LT.