Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

Atreya, Chintamani; Glynn, Simone; Busch, Michael; Kleinman, Steve; Snyder, Edward; Rutter, Sara; AuBuchon, James; Flegel, Willy; Reeve, David; Devine, Dana; Cohn, Claudia; Custer, Brian; Goodrich, Raymond; Benjamin, Richard J.; Razatos, Anna; Cancelas, Jose; Wagner, Stephen; Maclean, Michelle; Gelderman, Monique; Cap, Andrew; Ness, Paul

Pooling has the added benefit of diluting allergens by approximately 1000-fold, which reduces the risk of allergic reactions. Multiple studies have shown a comparative reduction in the rate of allergic reactions (Table 3) . [95] [96] [97] [98] [99] [100] [101] Pooling likely mitigates the risk of TRALI by diluting and neutralizing antibodies to human neutrophil antigen and HLA. The S/D process also removes bioactive lipids, which have been implicated as a causative factor in TRALI. While proving a negative is impossible, there have been more than 10 million units of Octaplas transfused with zero incidence of TRALI reported. 59 The levels of coagulation factors, protease inhibitors, and cofactors are tested for each lot before release. Older versions of S/D plasma were associated with hyperfibrinolysis and bleeding; 102-104 however, changes to the manufacturing process have mitigated the risk of these adverse events. 105 In several studies conducted with the current version of Octaplas, no additional risk of these or other adverse events was identified. 96, [105] [106] [107] [108] [109] [110] No clinically relevant differences in efficacy were identified; however, most of these studies were small and may not have been powered to show significant differences. 96, [105] [106] [107] [108] [109] [110] [111] The University of Minnesota has chosen to maintain an inventory of Octaplas for patients who have a history of moderate to severe allergic transfusion reactions. It is especially helpful for patients who are undergoing plasma exchange, as they must contend with multiple units of conventional plasma. The extra time and effort saved by the reduction of reactions plus the increased comfort and safety experienced by the patient make the added cost of Octaplas worthwhile. In conclusion, the efficacy and safety profiles of Octaplas make it a good alternative to conventional plasma, and it is beneficial for patients with a history of allergic transfusion reactions.