Stability of Thawed Apheresis Fresh-Frozen Plasma Stored for up to 120 Hours at 1°C to 6°C

Abstract

Regulations concerning the storage of transfusable plasma differ internationally. In Canada, plasma obtained from whole blood donations and frozen within 24 hours of phlebotomy (frozen plasma, FP) may be thawed and transfused within 120 hours of refrigerated storage. However, plasma frozen within 8 hours of phlebotomy following apheresis donation (FFPA) must be transfused within 24 hours of thawing and refrigeration. Our objectives were to measure coagulation factors (F) V, VII, and VIII, fibrinogen activities, and the prothrombin time (PT) in thawed refrigerated FFPA at 0, 24, and 120 hours of storage and to compare these values to those in thawed refrigerated FP. Fibrinogen activity remained unchanged over time, while mean factor levels in 28 FFPA units declined by 17% (FV), 19.7% (FVII), and 54.6% (FVIII) over 120 hours, while PT values rose to 7.6%. Factor activities were significantly higher in FFPA than FP after 120 hours of refrigerated storage. Residual FVIII activities in thawed FFPA met predefined noninferiority criteria compared to thawed FP after 120 hours. These results support a change in Canadian regulations to permit transfusion of thawed FFPA made in a closed system and refrigerated for up to 120 hours, one that could reduce wastage of transfusable plasma.

Ex vivo haemostatic capacity of plasma upon thawing and beyond: a comparison between fresh frozen plasma (FFP) and frozen plasma prepared from whole blood stored at room temperature up to 24 hours postcollection (RTFP24)

“…Most of the declines were minor albeit statistically significant when compared to their respective baselines at the time of thaw. The bulk of the decline occurred within the first 24 h post‐thaw which corresponds to the current shelf life when stored at 1–6°C . Although coagulation factors in FFP and RTFP24 at 96 h post‐thaw were mostly within our laboratory's reference ranges, we observed significantly poorer thrombin generation potential in both FFP and RTFP24 at 96 h post‐thaw compared to their respective baselines.…”

“…Extending the shelf life of thawed plasma could facilitate the availability of prethawed plasma for massive transfusion protocol and reduce the wastage of thawed plasma. Evidence from studies involving thawed FFP and FP24 has found that coagulation factors were generally maintained within the reference ranges and met quality standards when stored up to 5 days . Similar data on thawed RTFP24 are limited .…”

“…While there is published literature establishing the equivalence between FFP and RTFP24 upon thawing, few have compared global assays of haemostasis like thrombin generation. There were also less published literature reports on extended storage of thawed RTFP24 as most were conducted on thawed FFP or FP24 , and most did not directly compare RTFP24 with FFP beyond 24 h post‐thaw.…”

Fresh frozen plasma and platelet concentrate storage duration not associated with in hospital mortality risk

“…Notably, this pooled patient meta‐analysis also delivered results relevant to countries with short FFP storage durations (e.g. 12 months) such as Australia and Canada . For example, FFP is stored for 12 months with most FFP transfused within the first 3 months of storage in Australia.…”

Thawed solvent/detergent‐treated plasma demonstrates comparable clinical efficacy to thawed plasma

“…[4][5][6][7][8] However, studies suggest that factor levels in TP are sufficient for its safe use in the treatment of frequently encountered coagulopathies. 4,7,[9][10][11] Plasma transfusion can be associated with both infectious and non-infectious complications. The overall risk of transfusion-transmitted infections (TTIs) is low, but remain a major concern in transfusion medicine, 12 especially untested emerging pathogens.…”