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The bioequivalence of frozen plasma prepared from whole blood held overnight at room temperature compared to fresh‐frozen plasma prepared within eight hours of collection
Author(s) -
Dumont Larry J.,
Cancelas Jose A.,
Maes Lou Ann,
Rugg Neeta,
Whitley Pamela,
Herschel Louise,
Siegel Alan H.,
Szczepiorkowski Zbigniew M.,
Hess John R.,
Zia Majid
Publication year - 2015
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.12864
Subject(s) - fresh frozen plasma , confidence interval , bioequivalence , leukoreduction , blood collection , medicine , whole blood , surgery , chemistry , chromatography , anesthesia , pharmacokinetics , blood transfusion , emergency medicine , platelet
Background Overnight, room temperature hold of whole blood ( WB ) before leukoreduction and component processing offers significant logistic and cost advantages over WB processed within 8 hours. Plasma prepared from WB held at room temperature overnight ( PF24RT24WB ) may result in a degradation of plasma coagulation protein activities compared to plasma frozen within 8 hours of collection. In this study, we intended to evaluate the bioequivalence ( BE ) of PF24RT24WB prepared using a new WB collection, leukoreduction, and storage system compared to fresh‐frozen plasma ( FFP ) after 12 months of frozen storage. Study Design and Methods We conducted a three‐center, three‐arm evaluation of the LEUKOSEP HWB ‐600‐ XL test system ( H emerus M edical LLC ) compared to the RZ 2000 control ( F enwal, I nc.). FFP was prepared from WB held at room temperature more than 6 hours and placed at less than −18° C by 8 hours for control (n = 60) and test (n = 60) arms. PF24RT24WB (n = 60) was prepared with the test system from WB held at room temperature and then filtered and processed 20 to 24 hours postcollection. Frozen plasma was tested at 3, 6, and 12 months using a comprehensive panel of protein and coagulation factor assays. Results The test FFP was BE for all coagulation factors and tested proteins at 12 months. As expected, PF24RT24WB had a reduced F actor ( F ) VIII activity compared to control FFP (87.1%; 90% confidence interval, 79.4%‐93.3%) with the lower confidence limit less than 80%. All other factors were within the BE region. Conclusion Leukoreduced FFP and PF24RT24WB prepared using the LEUKOSEP HWB ‐600‐ XL system has been shown to be BE to control leukoreduced FFP with an expected decrease in FVIII activity after overnight hold.