Highlights
- •Reconstituted fibrinogen concentrate is stable for up to a week post-reconstitution.
- •Extending expiration could reduce product wastage and pre-emptive reconstitution.
- •Pre-emptive reconstitution could facilitate timely delivery in trauma scenarios.
Abstract
Background and objectives
Reconstituted 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 methods
Reconstituted 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.
Results
Reconstituted 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).
Conclusion
Fibryga® 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
Keywords
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Article info
Publication history
Published online: February 14, 2023
Accepted:
February 13,
2023
Received in revised form:
October 4,
2022
Received:
August 9,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Ltd. All rights reserved.
