Martini Wenjun Z, Guzman Rodolfo de, Dubick Michael A
U.S. Army Institute of Surgical Research, Joint Base San Antonio, 3650 Chambers Pass, Fort Sam Houston, TX 78234-6135.
Mil Med. 2018 Mar 1;183(suppl_1):183-188. doi: 10.1093/milmed/usx176.
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.
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.
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.
Fibrinogen concentrate maintained its content and function when stored at -20°C to 50°C with up to 80% humidity for 6 mo.
本研究旨在评估纤维蛋白原浓缩物在野外条件下观察到的温度和持续时间变化时的稳定性和功能活性。
将纤维蛋白原浓缩物分别储存在-20°C（12瓶）、22°C（12瓶）和50°C、湿度80%（12瓶）的环境中，长达6个月。在每个温度下，分别在0、1、3和6个月时取出3瓶纤维蛋白原浓缩物并进行复溶。在分析当天，从一名健康供体采集血样以获取血浆样本。将供体血浆与市售缺乏纤维蛋白原的血浆混合制成纤维蛋白原调整血浆（FAP）。复溶后的纤维蛋白原浓缩物的一份用于定量FAP中储存的纤维蛋白原含量（使用STA-R）和功能（Rotem - Fibtem）。
在22°C下储存0、1、3和6个月时，纤维蛋白原含量（1223±42mg/瓶、1286±86mg/瓶、1234±76mg/瓶和1178±64mg/瓶）、凝血酶原时间（13.5±0.1秒、13.7±0.6秒、13.3±0.4秒和13.7±0.2秒）或活化部分凝血活酶时间（31.1±0.2秒、32.0±0.2秒、31.5±0.2秒和32.0±0.8秒）均未观察到显著变化。Fibtem测量的任何结果也未观察到显著变化。同样，在-20°C和50°C、湿度80%的条件下，随着时间推移这些变量也未观察到差异。
纤维蛋白原浓缩物在-20°C至50°C、湿度高达80%的条件下储存6个月时，其含量和功能保持不变。
