Stability of Fibrinogen Concentrate in Human Blood Samples: An In Vitro Study.

Objectives: This study was designed to assess the stability and functional activity of fibrinogen concentrates subjected to the changes in temperature and duration observed in field conditions. Methods: Fibrinogen concentrate was stored at-20 degrees C (12 vials), 22 degrees C (12 vials), and 50 degrees C with 80% humidity (12 vials), for up to 6 mo. At each temperature, three vials of fibrinogen concentrate were taken out at 0, 1, 3, and 6 mo and reconstituted. On analysis days, blood samples were taken from a single healthy donor to collect plasma samples. The donor plasma was mixed with commercial fibrinogen-deficient plasma to make fibrinogen-adjusted plasma (FAP). An aliquot of the reconstituted fibrinogen concentrate was used for quantification of stored fibrinogen content (using STA-R) and function (Rotem Fibtem) in FAP. Results: At 22 degrees C for 0, 1, 3, and 6 mo, there were no significant changes observed in fibrinogen content (1,223 +/- 42mg/vial, 1,286 +/- 86 mg/vial, 1,234 +/- 76mg/vial, and 1,178 +/- 64mg/vial), prothrombin time (13.5 +/- 0.1 s, 13.7 +/- 0.6 s, 13.3 +/- 0.4 s, and 13.7 +/- 0.2 s), or activated partial thromboplastin time (31.1 +/- 0.2 s, 32.0 +/- 0.2 s, 31.5 +/- 0.2 s, and 32.0 +/- 0.8 s), respectively. There were also no significant changes observed in any of the Fibtem measurements. Similarly, no differences were observed in these variables over time at-20 degrees C and 50 degrees C with 80% humidity. Conclusions: Fibrinogen concentrate maintained its content and function when stored at-20 degrees C to 50 degrees C with up to 80% humidity for 6 mo.