VPB0572 - A study of the stability of fibrinogen and FXIII levels and microbial integrity of pooled cyroprecipitate stored at 1-6°C and 20-24°C for up to 120 hours

Background: Cryoprecipitate is an important source of fibrinogen and FXIII, both of which are depleted in trauma induced coagulopathy. Current standards stipulate its post-thaw storage at 20-24°C and transfusion within 4-6 hours post-thaw, however this is a potential limiting factor in its timely availability during major bleeding. Though recent studies demonstrate stability of fibrinogen levels in post-thaw cryoprecipitate stored at 20-24°C for up to 5 days, the risk of bacterial growth remains a concern.

Aims: To investigate the ex-vivo haemostatic capacity and risk of bacterial contamination of thawed cryoprecipitate stored at 1-6°C and room temperature (20-24°C) over 120 hours

Methods: 10 units of pre-pooled cryoprecipitate were thawed at 37°C and split into 2 arms (1-6°C and 20-24°C). Fibrinogen levels were assessed at 0, 24, 48, 72, 96 and 120 hours, while FXIII levels was assessed at 0 and 120 hour for each arm.
For sterility testing, 10 units of pre-pooled were thawed at 37°C and split into 2 arms (1-6°C and 20-24°C). Aerobic and anaerobic cultures were performed at 0, 24, 72 and 120 hour for each arm. Incubation period was 5 days at each time point.

Results: Decline in fibrinogen concentration was noted from Day 0 to 5 for the cryoprecipitate stored at 1-6°C (median decline 3.5g/L). Conversely, fibrinogen levels in cryoprecipitate stored at room temperature remained more constant (median decline 0.6g/L). Nevertheless, all cryoprecipitate samples met HSA’s QC requirement of > 150mg of fibrinogen/unit at Day 5. Likewise, there was a decline in FXIII levels from Day 0 to 5 at both 1-6°C (median decline 27.0IU/dL) and at 20-24°C (median decline 12.5IU/dL). The percentage decline in FXIII levels for both arms was however small. Sterility testing was negative for all units.

Conclusion(s): This study demonstrates potential feasibility in storing cryoprecipitate at 1-6°C for 5 days while maintaining fibrinogen and FXIII levels.