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

The WB Mirasol program has been developed in partnership with the US Department of Defense (DOD). The African Investigation of Mirasol System (AIMS) clinical trial at the Komfo Anokye Teaching Hospital in Kumasi, Ghana, is the first and only clinical trial to demonstrate that PRT can effectively reduce the incidence of TTI of a blood-borne pathogen. The test arm consisted of Mirasol-treated nonleukoreduced WB and the control arm consisted of untreated nonleukoreduced WB. 123 Sixty-five nonparasitemic patients were exposed to parasitemic blood; 28 received Mirasoltreated WB and 37 received untreated WB. 123 The incidence of transfusion-transmitted malaria was significantly lower for the patients receiving Mirasol-treated WB (one [4%] of 28 patients) compared to patients receiving untreated WB (eight [22%] of 37 patients; p = 0Á039). 123 Moreover there were no significant differences in 1) total Hb for up to 28 days posttransfusion and 2) adverse events between Mirasol-treated WB and untreated WB. 123 The success of the AIMS clinical trial supported CE mark of the Mirasol PRT system for the treatment of WB for transfusion.