Spray‐dried plasma is comparable to conventional plasma products used in the resuscitation of major hemorrhage: In vitro characterization

BACKGROUND: Prehospital transfusion of blood products to patients at risk for hemorrhagic shock reduces mortality. Prehospital availability of blood products is limited by logistical constraints. This study evaluated the characteristics and stability of a product manufactured using a novel system for spray-drying and packaging plasma into plastic transfusion bags suitable for prehospital use. STUDY DESIGN AND METHODS: Plasma units dried using the spray-drying system (FrontlineODP-OnDemand Plasma), were rehydrated and compared to paired, frozen controls across a range of characterization assays. Testing was completed for initial characterization, stability post-rehydration to 26 h at refrigeration (1°C-6°C) and room temperature (20°C-24°C), and long-term stability at refrigeration for 24 months and at room temperature for 6 and 12 months. RESULTS: The spray-drying process converted liquid plasma into a fine, dry powder stored in a plastic transfusion-ready bag. The mean time to rehydrate was 2 min and 37 s. The characterization study demonstrated that dried plasma units were comparable to paired controls with similar coagulation factor activities, clotting times, balance of pro- and anticoagulation factor activities, markers of activation, pH, and chemistries. Spray-dried plasma was stable after rehydration for 26 h at refrigeration and room temperature. Spray-dried plasma maintained functional characteristics for 24 months at refrigeration and demonstrated comparability to 5-day thawed plasma after room temperature storage for 12 months. DISCUSSION: Spray-dried plasma rehydrates rapidly and has in vitro characteristics comparable to standard-of-care products after storage at room temperature for 1 or 2 years refrigerated. Clinical study of spray-dried plasma is warranted.