Department of Pathology and Laboratory Medicine, University of British Columbia, Rm. G227-2211 Wesbrook Mall, Vancouver, BC V6T 2B5, Canada; Department of Pathology and Laboratory Medicine, Vancouver General Hospital, 2775 Laurel Street, Vancouver, BC V5Z 1M9, Canada.
Department of Pathology and Laboratory Medicine, University of British Columbia, Rm. G227-2211 Wesbrook Mall, Vancouver, BC V6T 2B5, Canada; Department of Pathology and Laboratory Medicine, Vancouver General Hospital, 2775 Laurel Street, Vancouver, BC V5Z 1M9, Canada.
Transfus Apher Sci. 2023 Jun;62(3):103657. doi: 10.1016/j.transci.2023.103657. Epub 2023 Feb 14.
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.
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.
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).
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.
根据产品说明书，复溶纤维蛋白原浓缩物在 8-24 小时内被认为是稳定的。鉴于纤维蛋白原在体内的半衰期较长（3-4 天），我们假设复溶的无菌纤维蛋白原蛋白的稳定性将超过 8-24 小时。延长复溶纤维蛋白原浓缩物的有效期可以减少浪费，并提前进行复溶，以最大限度地减少周转时间。我们进行了一项试点研究，以确定复溶纤维蛋白原浓缩物随时间的稳定性。
将 64 瓶来自 Octapharma AG 的 Fibryga®复溶后储存在控温冰箱（4°C）中，最长可达 7 天，使用自动化 Clauss 法连续测量功能性纤维蛋白原浓度。将样本冷冻，然后解冻并与混合正常血浆稀释，以便进行批量测试。
在整个 7 天的研究期间，储存在冰箱中的复溶纤维蛋白原样本的功能性纤维蛋白原浓度没有显著降低（p=0.63）。初始冷冻时间的长短对功能性纤维蛋白原水平没有不利影响（p=0.23）。
根据 Clauss 纤维蛋白原测定法，Fibryga®在复溶后可在 2-8°C 下储存长达一周，而功能性纤维蛋白原活性无损失。可能需要对其他纤维蛋白原浓缩物制剂进行进一步研究，并进行临床体内研究。
