Stability of Reconstituted Fibrinogen Concentrate in Hemostatic Function and Concentration

ABSTRACT Introduction Canadian Armed Forces adopted fibrinogen concentrate (RiaSTAP) for hemostatic resuscitation in the far-forward combat setting, given its potential benefits of reducing blood loss, transfusion and mortality, long storage stability high portability. The current guidance recommends that RiaSTAP should be administered within 8 hours after reconstitution when stored at room temperature. However, little information about is available. There also a need to investigate efficacy exposure extreme temperatures which our forces may operate. Materials Methods was reconstituted as per manufacturer’s instruction specific (?20°C, 4°C, 22°C, 35°C, 42°C, or 50°C) up 6 months. Reconstituted oscillated on rocker 18 rpm under 22°C 50°C. Its function measured using rotational thromboelastometry performed with RiaSTAP-spiked whole blood. Fibrinogen concentrations were by commercial enzyme-linked immunosorbent assay (ELISA) kit. Gel electrophoresis conducted initial samples. Results We found no change ?20°C At obvious changes effect relative 0 seen until 1,680 hours. remarkable decrease began 168 Storage 35°C significantly decreased 144 hours, while 42°C resulted 72 Finally, 50°C complete loss function. Compared activity, concentration showed less over time. No apparent decline months 4°C there clear alterations 792 672 600 storage, respectively. 50°C, amount detected ELISA Similar time observed rocking condition comparison static same gel confirmed degradation increased temperature Conclusions decreases increasing deteriorated before integrity altered all study period except where rapid both concentration. Sample oscillation did not affect stability. shelf life may, therefore, recommended accordingly different extended days provided sterility maintained.