Stability of fresh frozen plasma: Results of 36-month storage at -20 degrees C, -25 degrees C, -30 degrees C and -40 degrees C

Background: In October 1995, the Section 'Blood Plasma Constituents' of the DGTI initiated a multicenter trial with 3 fresh frozen plasma (FFP) pools in order to determine their stability during storage at 4 temperatures [-20 degrees C; -25 degrees C; -30 degrees C; -40 degrees C), as the European P harmacopoeia (EP) Monograph 'Human Plasma for Fractionation' contains no pa rticulars concerning the shelf life of FFP. The aim of the DGTI multicenter study was to test the stability of FFPs at 4 storage temperatures through characterization of individual proteins over a period of 36 months. The res ults of B-month storage of FFP at -20 degrees C and -25 degrees C have alre ady been published in 1997 [Kotitschke R, et al: Infusionsther Transfusions med 1997;24:397-403]. Material and Methods: The FFPs were supplied by 3 blo od donor services. Two FFPs were produced from whole blood and 1 from plasm apheresis plasma. The maximum times from blood collection to freezing of th e plasma samples which were first pooled and then bagged in aliquots and fr ozen were 6 h or 24 h, for the whole blood FFPs and 4 h for the plasmaphere sis plasma. The effect of storage on the plasma samples was investigated by determining the activity of clotting factors FVIII, FIX, FV, fibrinogen, t he activation products thrombin/antithrombin complex (TAT) and prothrombin fragments F1 + 2, the inhibitors antithrombin and C1-esterase inhibitor, th e IgG level, and the anti-HBs titer. Thirteen European laboratories took pa rt in the multicenter trial. The FFP proteins were determined using commerc ial reagents. Results: The stability of the FFPs during 24 or 36 months of storage at temperatures of -20 degrees C, -25 degrees C,-30 degrees C and - 40 degrees C was assessed by determining characteristic proteins in the FFP s. Comparison of the values determined for the various proteins at the star t of the FFP storage period with values obtained after 24 and 36 months ind icates that there were no significant changes in these proteins. Conclusion : The DGTI multicenter trial initiated by the Section 'Blood Plasma Constit uents' to determine the stability of FFP during 2 and 3 years of storage at 4 temperatures showed no detectable protein changes in the FFP.