新鲜冰冻血浆与晶体体外循环启动在小儿心脏手术中的比较：随机临床试验
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Fresh FrozenPlasma versus Crystalloid Priming of Cardiopulmonary Bypass Circuit in Pediatric Surgery: A Randomized Clinical Trial
背景与目的
在先天性心脏手术中，用新鲜冰冻血浆（FFP）预充体外循环（CPB）以防止凝血异常。假设在出血和/或输血需要方面，晶体启动与FFP预充CPB不同。
方 法
在这项平行双盲研究中，除了预先确定的用于所有患者的填充红细胞数量外，体重在7到15公斤之间的患者被随机分配到用15ml·kg-1晶体或15ml·kg-1 FFP启动的CPB中。输血的决定是临床上的，并以护理点试验为指导。主要终点包括胸导管追踪的术后出血、使用任何额外血液制品输血的患者人数、及术中和术后使用额外血液制品的总人数。术后时间为重症监护病房到达后6h。
结 果
对30例FFP组和29例血浆组患者进行了意向治疗分析。FFP组中的中位术后失血量为7.1mL·kg/1（5.1，9.4），晶体组的中位术后失血量为5.7mL·kg/1（3.8，8.5）（p=0.219）；差异（95%CI）：1.2（0.7至3.2）。在FFP和晶体组中，额外输血的患者比例分别为26.7%（8/30）和37.9%（11/29）（p=0.355；比值比[95%CI]，1.7[0.6至5.1]）。在FFP和晶体组中，除灌注外，输血外任何血液产品的中位数量分别为0（0，1）和0（0，2）（p=0.254；差异[95%CI]，0[0至0]）。没有研究相关的不良事件。
结 论
结果表明，在婴儿和儿童中，用晶体预充CPB并不会导致不同的术后出血风险，也不会导致异基因血制品需要输血的风险。
原始文献摘要
Dieu A, Rosal Martins M, Eeckhoudt S, Matta A, Kahn D, Khalifa C, Rubay J,Poncelet A, Haenecour A, Derycke E, Thiry D, Gregoire A, Momeni M. Fresh FrozenPlasma versus Crystalloid Priming of Cardiopulmonary Bypass Circuit in Pediatric Surgery: A Randomized Clinical Trial. Anesthesiology. 2019 Oct 23. doi:10.1097/ALN.0000000000003017.
Background: In congenital cardiac surgery, priming cardiopulmonary bypass (CPB) with fresh frozen plasma (FFP) is performed to prevent coagulation abnormalities. The hypothesis was that CPB priming with crystalloids would be different compared with FFP in terms of bleeding and/or need for blood product transfusion.
Methods: In this parallel-arm double-blinded study, patients weighing between and 15 kg were randomly assigned to a CPB priming with 15ml · kg−1 PlasmaLyte or 15ml · kg−1 FFP in addition to a predefined amount of packed red blood cells used in all patients. The decision to transfuse was clinical and guided by point-of-care tests. The primary endpoints included postoperative bleeding tracked by chest tubes, number of patients transfused with any additional blood products, and the total number of additional blood products administered intra- and postoperatively. The postoperative period included the first 6 h after intensive care unit arrival.
Results: Respectively, 30 and 29 patients in the FFP and in the crystalloid group were analyzed in an intention-to-treat basis. Median postoperative blood loss was 7.1ml · kg−1 (5.1, 9.4) in the FFP group and 5.7ml · kg−1(3.8, 8.5) in the crystalloid group (P = 0.219); difference (95% CI): 1.2 (−0.7 to 3.2). The proportion of patients additionally transfused was 26.7% (8 of 30) and 37.9% (11 of 29) in the FFP and the crystalloid groups, respectively (P = 0.355; odds ratio [95% CI], 1.7 [0.6 to 5.1]). The median number of any blood products transfused in addition to priming was 0 (0, 1) and 0 (0, 2) in the FFP and crystalloid groups, respectively (P = 0.254; difference [95% CI], 0 [0 to 0]). There were no study-related adverse events.
Conclusions: The results demonstrate that in infants and children, priming CPB with crystalloids does not result in a different risk of postoperative bleeding and need for transfusion of allogeneic blood products.
麻醉学文献进展分享
贵州医科大学高鸿教授课题组
翻译：任文鑫 编辑：何幼芹 审校：王贵龙