Coagulation factor stability and sterility of thawed fresh frozen plasma stored at 2-6 o C for five days: Towards optimizing utilization.

Abstract

Background: Fresh frozen plasma plays a crucial role in managing trauma and bleeding patients. The concern about a decline in labile coagulation factors limits its usage beyond 24 hours. This study aimed to analyze coagulation factor levels and microbial contamination of thawed fresh frozen plasma stored at 2-6 °C for five days.

Material and methods: A prospective observational study was conducted on 40 male donors with blood groups A and O selected through purposive sampling. Blood was collected in 450 mL bags and freshly prepared plasma was aliquoted and frozen at -80 °C. Aliquots were thawed at 37 °C and tested on Days 0, 1, and 5 after storage at 2-6 °C. Coagulation screening assays and activity of coagulation factors V, VIII, IX, fibrinogen, and von Willebrand factor were performed. Samples were tested for sterility on Day 5.

Results: One-way ANOVA revealed a significant increase in mean prothrombin time, activated partial thromboplastin time, and international normalized ratio during storage (p-value < 0.001). The activity of factors V and VIII showed a significant decrease over five days (factor V - 20.0 % and factor VIII - 42.2 %; p-value < 0.001), with factor VIII activity declining by 30.8 % within the first 24 hours and remaining relatively stable thereafter. Mean von Willebrand factor activity was lower in fresh frozen plasma from O blood group donors (p-value < 0.05) on Days 1 and 5 of storage using an unpaired t-test. Cultures were sterile on Day 5.

Conclusion: Key coagulation factors were well preserved in thawed plasma till five days of storage at 2-6 °C without compromising product sterility suggesting potential for extended shelf life.