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

There will be a measurable reduction in cell or protein quality after treatment Preclinical studies and clinical trials with PRTs conducted in the preceding 18 years have repeatedly demonstrated changes in both in vitro and in vivo variables. 129 These include changes in metabolic variables in treated PLTs, changes in aggregation, and adhesion function and changes in PLT proteomic and metabolomics measurements. 130 Similar results with plasma products have shown reduced coagulation factor levels after treatment. 131 Clinical studies evaluating the performance of these products have demonstrated noninferiority with regard to prevention of bleeding in patients with hematologic malignancies. Estcourt and colleagues, summarizing meta-analyses for 12 clinical trials with these products, indicated that "We found moderate-quality evidence that pathogen-reduced platelet transfusions do not affect all-cause mortality, the risk of clinically significant or severe bleeding, or the risk of a serious adverse event." 132, 133 The authors also noted that, "We found high-quality evidence that pathogenreduced platelet transfusions increase the risk of platelet refractoriness and the platelet transfusion requirement." 132, 133 Additives will be added to the blood supply that are not common blood additives or routinely present in the human body