Transfusion Requirements After Cardiac Surgery The TRACS Randomized Controlled Trial
Transfusion Requirements After Cardiac Surgery The TRACS Randomized Controlled Trial
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DOI：
10.1001/jama.2010.1446
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发表时间：
2010-10-13
影响因子：
120.7
通讯作者：
Auler, Jose O. C., Jr.
中科院分区：
文献类型：
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作者：
Hajjar, Ludhmila A.;Vincent, Jean-Louis;Auler, Jose O. C., Jr.
围手术期红细胞输血通常用于治疗贫血，贫血是心脏手术后发病率和死亡率的独立危险因素；然而，关于心脏手术患者最佳输血实践的证据是缺乏的。目的探讨择期心脏手术患者围手术期限制性红细胞输注策略是否与自由输注策略一样安全。心脏手术后输血需求研究（TRACS）是一项前瞻性、随机、对照临床非劣效性试验，于2009年2月至2010年2月在巴西一所大学医院心脏外科转诊中心的重症监护室进行。连续接受心脏手术合并体外循环的成人患者（n=502）符合条件；通过意向治疗进行分析。患者被随机分配到自由输血组（维持红细胞压积>= 30%）或限制性输血组（红细胞压积>= 24%）。住院期间发生的30天全因死亡率和严重发病率（心源性休克、急性呼吸窘迫综合征或需要透析或血液滤过的急性肾损伤）的复合终点。非劣效性界限设定为-8%（即复合终点发生的最低临床重要增加8%）。结果自由策略组血红蛋白浓度维持在平均10.5 g/dL(95%可信区间[CI]， 10.4-10.6)，限制策略组维持在平均9.1 g/dL（95% CI, 9.09.2）
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, 9.09.2) in the restrictive-strategy group (P