Five-day stability of thawed plasma: solvent/detergent-treated plasma comparable with fresh-frozen plasma and plasma frozen within 24 hours.

BACKGROUND: Plasma stored refrigerated for up to 5 days after thawing is common practice in many US hospitals. Therefore, clotting factor activities in fresh-frozen plasma (FFP), plasma frozen within 24 hours (PF24), and solvent/detergent-treated plasma (SDP), thawed and stored at 1 to 6°C for up to 5 days, were investigated. STUDY DESIGN AND METHODS: Five A, B, O, and AB units of FFP, PF24, and SDP were thawed and maintained for 5 days at 1 to 6°C. The activity of factor (F)V, FVII, FVIII, protein S (PS), and ADAMTS13 was determined in each unit at baseline and every 24 hours thereafter for 5 days. RESULTS: After thaw, mean values of the variables tested were within the normal range in all three plasma products although, in SDP, FVIII activity was significantly lower (p = 0.0039). After 5 days of storage all factors significantly declined except for ADAMTS13 activity, which was stable. Mean FVIII and ADAMTS13 activity was comparable in all three plasma products and within the normal range, mean FV activity was significantly lower in FFP and PF24 (p<0.0001) compared to SDP, and mean FVII activity was significantly lower in PF24 (p<0.03) than in FFP or SDP. Mean PS activity was below the normal range in all three plasma products with the lowest values in SDP (p = 0.0001). CONCLUSION: Over 5 days of refrigerated storage the changes in the measured coagulation factors in FFP, PF24, and SDP are comparable. Clinical follow-up is needed to assess whether slightly lower PS levels in SDP are clinically important.

The state of the art of removal of prion proteins in SD-FFP, by specific prion affinity chromatography and its impact on the hemostatic characteristics of the product.

In recent Coimbra' Conference, on the pre-launch of pathogen reduced-FFP for the local clinical use, the question was raised, by the moderator, on the efficacy of the current methodology used for prion removal processes and its influence on the overall quality and safety of the final product. This brief paper put together by speaker of this session and the moderator, as a consensus of opinions, which was largely discussed during Q&A session, to make it available to a large group of readers of transfusion apheresis science, who might be interested to this topic. In short the capacity of the current process of Octaplas to remove prion is in order of 5.6 log10/ID50 reduction based on several animal studies. Moreover the changes in coagulation and inhibitors are within acceptable range and bioequivalent to untreated FFP with no sign of inferiority. This paper describes in brief a technology update on solvent/detergent treated plasma, an alternative to FFP but with increased pathogen safety. The biochemical profile of the final product is comparable with FFP and contains all clinically relevant plasma proteins. Furthermore, Octaplas is a product that, in long term, reduces health care costs.

Prion safety of transfusion plasma and plasma-derivatives typically used for prophylactic treatment.

Reports about transfusion-related transmissions of variant Creutzfeldt-Jakob disease have urged the need for more information regarding the risk for prion contaminated units in the blood supply and the safety of transfusion plasma and biopharmaceuticals derived from this precious raw material. According to a possible epidemiological model, the risk in many European countries is the same or lower than that of human immunodeficiency virus. Comprehensive investigations have shown that the prion safety margin of both single-donor and pooled solvent/detergent treated transfusion plasma is high. Furthermore, prophylactic treatment using plasma-derivatives poses a very low risk in terms of prion disease despite extensive lifetime exposure.