1. Stability of Fibrinogen Concentrate in Human Blood Samples: An In Vitro Study.
- Author
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Martini, Wenjun Z, Guzman, Rodolfo de, and Dubick, Michael A
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FIBRINOGEN , *BLOOD sampling , *PROTHROMBIN time , *HUMIDITY , *HEMORRHAGE , *BIOCHEMISTRY , *BLOOD coagulation tests , *BLOOD gases analysis , *COMPARATIVE studies , *PHENOMENOLOGY , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *EVALUATION research , *PARTIAL thromboplastin time , *IN vitro studies - Abstract
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°C (12 vials), 22°C (12 vials), and 50°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°C for 0, 1, 3, and 6 mo, there were no significant changes observed in fibrinogen content (1,223 ± 42 mg/vial, 1,286 ± 86 mg/vial, 1,234 ± 76 mg/vial, and 1,178 ± 64 mg/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°C and 50°C with 80% humidity.Conclusions: Fibrinogen concentrate maintained its content and function when stored at -20°C to 50°C with up to 80% humidity for 6 mo. [ABSTRACT FROM AUTHOR]- Published
- 2018
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