Potential for prolongation of fibrinogen concentrates post-reconstitution

Abstract

Background and objectivesReconstituted fibrinogen concentrate is considered stable for 8–24 h based on product monographs. Given the long half-life of fibrinogen in vivo (3–4 days), we hypothesized that reconstituted sterile fibrinogen protein would remain stable longer than 8–24 h. Extending the expiry date for reconstituted fibrinogen concentrate could decrease wastage and facilitate reconstitution in advance to minimize turnaround times. We performed a pilot study to define the stability of reconstituted fibrinogen concentrates over time. Materials and methodsReconstituted Fibryga® (Octapharma AG) from 64 vials was stored in the temperature-controlled refrigerator (4 °C) for up to 7 days with functional fibrinogen concentration measured serially using the automated Clauss method. The samples were frozen, then thawed and diluted with pooled normal plasma in order for them to be batch tested. ResultsReconstituted fibrinogen samples stored in the refrigerator showed no significant reduction in functional fibrinogen concentration for the entire 7-day study period (p = 0.63). Duration of initial freezing had no detrimental effect on functional fibrinogen levels (p = 0.23). ConclusionFibryga® can be stored at 2–8 °C post-reconstitution for up to one week with no loss in functional fibrinogen activity based on Clauss fibrinogen assay. Further studies with other fibrinogen concentrate formulations and clinical in vivo studies may be warranted