Extended Validation of Transport Conditions of Thawed PF24 Units

BACKGROUND: The transport and storage conditions of thawed plasma are not strictly regulated by the FDA and applying red blood cell transport standard of 1-10 degrees Celcius to recently thawed plasma often results in high discard rates. This study evaluated the extended 120-hour (5-day) coagulation factor stability and sterility of thawed plasma frozen within 24 hours (PF24) following a 6-hour transport cooler simulation. STUDY DESIGN AND METHODS: Fourteen PF24 units (8 group O, 6 group B) were thawed at 30-37 degrees Celcius and assigned as control (n=7, direct 1-6 degrees Celcius refrigeration) or experiment (n=7) units. Experiment units were held at room temperature for 30 minutes, stored in validated transport coolers for 6 hours, and then transferred to 1-6 degrees Celcius refrigeration. Measurements of temperature, prothrombin time (PT), Factor V (FV) activity, and Factor VIII (FVIII) activity were conducted at 0-, 6-, 24-, and 120-hour post-thaw. Sterility testing was performed at 0-hour and 120-hour using automated aerobic and anaerobic blood cultures. RESULTS: No statistically significant differences were observed between control and experiment units at 120-hour for mean PT (15.09 vs. 15.16 seconds, p = .44), FV activity (81.14 vs. 74.57%, p = .23), or FVIII activity (61.86 vs. 53.00%, p = .22). Delta analysis (120h-0h) confirmed equivalent factor decay rates between groups. All bacterial cultures showed no growth at 120-hour. CONCLUSION: A 6-hour cooler time of thawed PF24 does not accelerate coagulation factor degradation or compromise sterility over an extended 5-day shelf life. These findings validate flexible inventory return policies, allowing blood banks to reduce product waste.