Validating transport conditions of fresh frozen plasma units.

Abstract

Background: Thawed fresh frozen plasma (FFP) is subject to coagulation factor degradation, particularly factors V and VIII, prompting strict storage guidelines of 1-6°C post-thaw. However, real-world clinical practice often involves temporary deviations from ideal conditions, especially during transport. This study evaluated whether thawed FFP stored in standard transport coolers maintains coagulation factor integrity.

Study design and methods: Fourteen FFP units were thawed at 30-37°C and divided into two groups: control units stored immediately at 4°C and experimental units exposed to simulated transport conditions in validated coolers for up to 6 h post-thaw. Samples were obtained at 0, 3, and 6 h for temperature measurement and coagulation testing, including factor V and VIII activity and prothrombin time (PT). A one-tailed t-test was used for statistical comparisons.

Results: While cooler-stored units exhibited higher temperatures at 3 and 6 h (p < .001), no significant differences were observed in factor V or factor VIII activity or PT between experimental and control groups at any time point. Delta analysis confirmed the stability of coagulation parameters over time.

Conclusion: Short-term storage of thawed FFP in validated transport coolers does not compromise coagulation factor activity or PT. These findings support the return of thawed plasma units to inventory when stored in transport coolers for up to 6 h, reducing unnecessary product waste without compromising product safety and efficacy.