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.

Abstract

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. We conducted a three-center, three-arm evaluation of the LEUKOSEP HWB-600-XL test system (Hemerus Medical LLC) compared to the RZ2000 control (Fenwal, Inc.). 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. The test FFP was BE for all coagulation factors and tested proteins at 12 months. As expected, PF24RT24WB had a reduced Factor (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. 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.