Stability of Reconstituted Fibrinogen Concentrate in Hemostatic Function and Concentration.

Military Medicine
Henry T Peng, Andrew Beckett

Abstract

Canadian Armed Forces adopted fibrinogen concentrate (RiaSTAP) for hemostatic resuscitation in the far-forward combat setting, given its potential benefits of reducing blood loss, blood transfusion and mortality, and its long storage stability and 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 its stability is available. There is also a need to investigate the stability and efficacy of RiaSTAP after reconstitution and exposure to extreme temperatures in which our forces may operate. RiaSTAP was reconstituted as per manufacturer's instruction and stored at specific temperatures (-20°C, 4°C, 22°C, 35°C, 42°C, or 50°C) for up to 6 months. Reconstituted RiaSTAP was also oscillated on a rocker at 18 rpm under 22°C and 50°C. Its hemostatic function was measured using rotational thromboelastometry performed with RiaSTAP-spiked whole blood. Fibrinogen concentrations were measured by a commercial enzyme-linked immunosorbent assay (ELISA) kit. Gel electrophoresis was also conducted for initial and stored samples. We found no change to the hemostatic function of reconstituted RiaSTAP after storage a...Continue Reading

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