(P-BB-25) Comparison of Cryoprecipitated AHF Manufactured from FFP and PF24

Background/Case Studies: This is one large southeastern United States blood center’s experience with implementation of manufacturing Cryoprecipitated antihemophilic factor (CryoAHF) from plasma frozen within 24 hours of collection (PF24) as compared to fresh frozen plasma (FFP), which is frozen within 8 hours of collection.

Study

Design/Methods: The blood center evaluated factor VIII (FVIII) and fibrinogen testing results of 481 CryoAHF from FFP, consisting of Cryo Singlets (standard CryoAHF units), Cryo5 (pools of 5 standard CryoAHF units) and Cryo10 (pools of 10 standard CryoAHF units), over a 12-month period prior to implementation of manufacturing CryoAHF from PF24. Post-implementation, FVIII and fibrinogen results were evaluated for 482 CryoAHF from PF24, consisting of Cryo Singlets, Cryo5 and Cryo10 pools, over a 12-month period. The results from both evaluations were compared with the aid of a t-test to demonstrate statistical significance.

Results/Findings: For Cryo Singlet samples, there was no significant difference in the test values for CryoAHF from FFP and CryoAHF from PF24. Among the Cryo5 samples, there was no statistically significant difference between the FVIII values for CryoAHF from FFP and CryoAHF from PF24, however the fibrinogen results were significantly higher in the CryoAHF from PF24, with a p value of 0.009. Out of the Cryo10 samples tested, the FVIII and fibrinogen results were marginally higher for CryoAHF from PF24 as compared to CryoAHF from FFP but there is no statistically significant difference. See Table 1. The minimum AABB and FDA requirements of ≥ 80 IU of FVIII per unit and ≥ 150 mg of fibrinogen per unit were exceeded in all samples tested.

Conclusions: This study confirmed CryoAHF prepared from plasma frozen within 8 hours or 24 hours of collection meet FDA and AABB requirements, are comparable in potency in standard CryoAHF units, and CryoAHF from plasma frozen within 24 hours demonstrate improved FVIII and fibrinogen results in pools.

Importance of research: The importance of this study is to confirm the efficacy of new blood component manufacturing modalities.