Stability of coagulation factors in plasma prepared after a 24‐hour room temperature hold

Abstract

The manufacture of fresh-frozen plasma (FFP) requires that plasma be frozen within 8 hours of collection and 24-hour frozen plasma requires 1 to 6°C refrigeration before freezing. Manufacture of plasma after a room temperature hold for 24 hours, while convenient, could compromise clotting factor levels. Pairs of FFP and 24-hour room temperature-frozen plasma (PLT-rich plasma [PRP]-24HRTFP) were manufactured from PRP after a room temperature hold for 8 and 24 hours, respectively. Additional whole blood (WB) donations were kept at room temperature for 24 hours before plasma manufacture (WB-24HRTFP). The frozen plasma products were stored at -18°C, thawed, and then stored at 1 to 6°C, with coagulation factor assays performed for up to 7 days. On the day of thaw, Factor (F)VIII was lower in PRP-24HRTFP by 13% (p = 0.002) but not in WB-24HRTFP (p = 0.3) compared to FFP. All other clotting factors were within normal range. During the postthaw period FVIII and FV declined 25 and 6%, respectively, in WB-24HRTFP and 23 to 50% in the paired products; however, the difference between both types of 24HRTFP and FFP is insignificant by Day 7 (p > 0.05). Other clotting factors either were unchanged or showed minimal reduction (< 15%). Plasma manufactured after a 24-hour room temperature hold contains coagulation factors comparable to FFP except for a possible reduction of up to 20% in FVIII. This plasma appears suitable as a transfusable product and extension of liquid storage to 7 days merits consideration.