Author: Kleinman, Steve; Stassinopoulos, Adonis
Title: Risks associated with red blood cell transfusions: potential benefits from application of pathogen inactivation Document date: 2015_8_25
ID: qlddzgbg_28
Snippet: Potential risks of transfusing PI-RBCs include toxicologybased adverse side effects, increased RBC alloimmunization, and reduced clinical benefit to patients (i.e., efficacy). Extensive toxicology data for both PI-RBC systems are available in the literature. 132, 133 Such data have been reviewed by regulatory agencies and found robust enough to authorize Phase II and III clinical trial work. With regard to the primary chemical agents, S-303 compl.....
Document: Potential risks of transfusing PI-RBCs include toxicologybased adverse side effects, increased RBC alloimmunization, and reduced clinical benefit to patients (i.e., efficacy). Extensive toxicology data for both PI-RBC systems are available in the literature. 132, 133 Such data have been reviewed by regulatory agencies and found robust enough to authorize Phase II and III clinical trial work. With regard to the primary chemical agents, S-303 completely decomposes during the 20-hour treatment process and, in addition, the chemically inert reaction by-products are significantly reduced through the exchange step. Riboflavin and its photodegradation products have a toxicology profile of "generally regarded as safe." Nevertheless, potential long-term toxicology risks can only be definitively assessed by collecting routine use data.
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