Short-term temperature excursion does not affect plasma and cryoprecipitate quality.

BACKGROUND AND

OBJECTIVES

Plasma and cryoprecipitate are stored below -25°C for optimal preservation of component quality. However, there may be situations in which components are exposed to higher temperatures and therefore discarded. This study aimed to determine the quality of plasma and cryoprecipitate following a short-term temperature excursion to inform a possible shelf life.

MATERIALS AND

METHODS

Apheresis and whole blood (WB)-derived fresh frozen plasma (FFP; n = 68 and n = 37, respectively) and cryoprecipitate components (apheresis n = 78 and WB n = 80) that incurred a temperature excursion up to -11°C were returned to -25°C. Coagulation factors were measured at 1 month (baseline), 3 months and 6 months post excursion.

RESULTS

There were no significant differences in factor VIII (FVIII) concentrations in apheresis- and WB-derived plasma and apheresis-derived cryoprecipitate between 1 month, 3 months and 6 months (p = 0.236, p = 0.249 and p = 0.815, respectively). Activated partial thromboplastin time and prothrombin time increased slightly in plasma over storage but were not significantly different from baseline. Fibrinogen, von Willebrand Factor (VWF), protein C and immunoglobulin G were stable in plasma and cryoprecipitate.

CONCLUSION

The data demonstrate that plasma and cryoprecipitate that incurred a temperature excursion can meet quality control specifications when stored for 6 months post temperature excursion.