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Randomized Controlled Trial Comparative Study
Fresh Frozen Plasma versus Crystalloid Priming of Cardiopulmonary Bypass Circuit in Pediatric Surgery: A Randomized Clinical Trial.
- Audrey Dieu, Maria Rosal Martins, Stephane Eeckhoudt, Amine Matta, David Kahn, Céline Khalifa, Jean Rubay, Alain Poncelet, Astrid Haenecour, Emilien Derycke, Dominique Thiry, André Gregoire, and Mona Momeni.
- From the Departments of Anesthesiology (A.D., M.R.M., A.M., D.K., C.K., M.M.) Hematology (S.E.) Cardiac Surgery (J.R., A.P.) Perfusion Services (D.T., A.G.) the Pediatric Intensive Care Unit (A.H., E.D.), University Hospital Saint Luc, Catholic University of Louvain (Cliniques Universitaires Saint Luc, Université Catholique de Louvain), Brussels, Belgium.
- Anesthesiology. 2020 Jan 1; 132 (1): 95-106.
BackgroundIn 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.MethodsIn this parallel-arm double-blinded study, patients weighing between 7 and 15 kg were randomly assigned to a CPB priming with 15 ml · kg PlasmaLyte or 15 ml · kg 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.ResultsRespectively, 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 7.1 ml · kg (5.1, 9.4) in the FFP group and 5.7 ml · kg (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.ConclusionsThe 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.
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