Murphy G J, Verheyden V, Wozniak M, Sullo N, Dott W, Bhudia S, Bittar N, Morris T, Ring A, Tebbatt A, Kumar T
Department of Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit , University of Leicester, Clinical Sciences Wing, Glenfield Hospital , Leicester , UK.
University Hospitals Coventry and Warwickshire NHS Trust , Coventry , UK.
Open Heart. 2016 Mar 7;3(1):e000344. doi: 10.1136/openhrt-2015-000344. eCollection 2016.
It has been suggested that removal of proinflammatory substances that accumulate in stored donor red cells by mechanical cell washing may attenuate inflammation and organ injury in transfused cardiac surgery patients. This trial will test the hypotheses that the severity of the postoperative inflammatory response will be less and postoperative recovery faster if patients undergoing cardiac surgery receive washed red cells compared with standard care (unwashed red cells).
Adult (≥16 years) cardiac surgery patients identified at being at increased risk for receiving large volume red cell transfusions at 1 of 3 UK cardiac centres will be randomly allocated in a 1:1 ratio to either red cell washing or standard care. The primary outcome is serum interleukin-8 measured at 5 postsurgery time points up to 96 h. Secondary outcomes will include measures of inflammation, organ injury and volumes of blood transfused and cost-effectiveness. Allocation concealment, internet-based randomisation stratified by operation type and recruiting centre, and blinding of outcome assessors will reduce the risk of bias. The trial will test the superiority of red cell washing versus standard care. A sample size of 170 patients was chosen in order to detect a small-to-moderate target difference, with 80% power and 5% significance (2-tailed).
The trial protocol was approved by a UK ethics committee (reference 12/EM/0475). The trial findings will be disseminated in scientific journals and meetings.
ISRCTN 27076315.
有人提出，通过机械性细胞洗涤去除储存供体红细胞中积累的促炎物质，可能会减轻心脏手术输血患者的炎症反应和器官损伤。本试验将检验以下假设：与标准治疗（未洗涤红细胞）相比，接受心脏手术的患者输注洗涤红细胞后，术后炎症反应的严重程度会更低，术后恢复会更快。
在英国3家心脏中心之一被确定为接受大量红细胞输血风险增加的成年（≥16岁）心脏手术患者，将按1:1的比例随机分配接受红细胞洗涤或标准治疗。主要结局是术后96小时内5个时间点测量的血清白细胞介素-8。次要结局将包括炎症、器官损伤的测量指标、输血量以及成本效益。分配隐藏、按手术类型和招募中心分层的基于互联网的随机化以及结局评估者的盲法将降低偏倚风险。该试验将检验红细胞洗涤相对于标准治疗的优越性。选择170名患者作为样本量，以便检测小到中等的目标差异，检验效能为80%，显著性水平为5%（双侧）。
试验方案已获得英国伦理委员会批准（参考编号12/EM/0475）。试验结果将在科学期刊和会议上发表。
ISRCTN 27076315。
