CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
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Evaluation of coagulation factors and platelet function from an off-line modified ultrafiltration technique for post-cardiopulmonary bypass circuit blood recovery.

Perfusion 2013 May
Modified ultrafiltration (MUF) is a technique that hemoconcentrates residual CPB circuit blood and the patient at the same time. Hemoconcentration and MUF are Class 1-A recommendations in the anesthesia and surgical blood conservation guidelines. This study evaluated the off-line MUF process of the Hemobag (HB, Global Blood Resources, Somers, CT, USA) to quantitate coagulation factor levels, platelet (PLT) count and function in one facility and cellular growth factor concentrations of the final product that were transfused to the patient in another facility In two cardiac surgery facilities, after decannulation, the extracorporeal circuit (ECC) blood from 22 patients undergoing cardiac surgery was processed with the HB device. In eleven patients from the first facility by the study design, blood samples for coagulation factor levels and PLT aggregation were drawn from the reservoir of the MUF device pre- and post-processing. The samples (n = 11) were sent to a reference laboratory where testing for prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), reptilase time, fibrinogen, clotting factors II, V, VII, VIII, IX, X, ADAMTS-13, protein C, protein S, antithrombin III, von Willebrand Factor (vWF), and platelet (PLT) aggregation were performed. A portion of the final concentrated HB blood samples (n = 5-10) from the second facility by design were evaluated for transforming and platelet-derived cellular growth factor concentrations. On average, approximately 800 - 2000 mls of whole blood were removed from the ECC post-CPB for processing in the HB device. After processing, there was, on the average, approximately 300 - 950 mls of concentrated whole blood salvaged for reinfusion. The PT and INR were significantly lower in the post-processing product compared to the pre-processing samples while the aPTT times were not significantly different. All coagulation factors and natural anti-coagulants were significantly increased in the final product. The PLT number, although increased by 24%, was not statistically significant. While PLT function assays showed a statistically significant decrease in the levels post-processing, there was substantial platelet function in the MUF product. Overall, the decrease in function was in the range of 10% to 15%. Final product PDGF-αβ and TGF-β1 averaged 11,048 and 2,040 pg/ml, respectively. In these two case series, (ECC) circuit blood concentrated using the HB device showed coagulation studies with significantly lower PT and INR and significantly increased levels of all clotting factors. The findings are similar to trends reported in other studies utilizing conventional MUF and the HB. Functioning platelets remain in the final product, with growth factor concentrations similar to some methods employed to create platelet concentrates to enhance coagulation. Based on the ability of the HB off-line MUF procedure to concentrate circuit blood, the clinical utility of the HB device to decrease allogeneic blood product exposure should be evaluated in a prospective randomized clinical trial.

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