Winter Kelly M, Webb Rachel G, Mazur Eugenia, Dennington Peta M, Marks Denese C
Research and Development, Australian Red Cross Lifeblood, Alexandria, New South Wales, Australia.
Pathology Services, Australian Red Cross Lifeblood, Alexandria, New South Wales, Australia.
Vox Sang. 2024 Dec;119(12):1257-1267. doi: 10.1111/vox.13736. Epub 2024 Sep 18.
The post-thaw shelf-life of cryoprecipitate is 6 h, leading to high wastage. Storage of thawed cryoprecipitate at refrigerated temperatures may be feasible to extend the shelf-life. This study aimed to evaluate the quality of thawed cryoprecipitate stored at 1-6°C for up to 14 days.
Cryoprecipitate (mini- and full-size packs derived from both apheresis and whole blood [WB] collections) was thawed, immediately sampled and then stored at 1-6°C for up to 14 days. Mini-packs were sampled at 6, 24, 48 and 72 h, day 7 and 14; full-size cryoprecipitate was sampled on day 3, 5 or 7. Coagulation factors (F) II, V, VIII, IX, X and XIII, von Willebrand factor (VWF) and fibrinogen were measured using a coagulation analyser. Thrombin generation was measured by calibrated automated thrombogram.
FVIII decreased during post-thaw storage; this was significant after 24 h for WB (p = 0.0002) and apheresis (p < 0.0001). All apheresis and eight of 20 WB cryoprecipitate met the FVIII specification (≥ 70 IU/unit) on day 14 post-thaw. Fibrinogen remained stable for 48 h, and components met the specification on day 14 post-thaw. There were no significant differences in VWF (WB p = 0.1292; apheresis p = 0.1507) throughout storage. There were small but significant decreases in thrombin generation lag time, endogenous thrombin potential and time to peak for both WB and apheresis cryoprecipitate.
Whilst coagulation factors in cryoprecipitate decreased after post-thaw storage, the thawed cryoprecipitate met the Council of Europe specifications when stored at refrigerated temperatures for 7 days.
冷沉淀解冻后的保存期限为6小时，导致大量浪费。在冷藏温度下储存解冻后的冷沉淀可能是延长保存期限的可行方法。本研究旨在评估在1-6°C下储存长达14天的解冻冷沉淀的质量。
冷沉淀（来自单采和全血采集的小型和全尺寸包装）解冻后立即取样，然后在1-6°C下储存长达14天。小型包装在6、24、48和72小时、第7天和第14天取样；全尺寸冷沉淀在第3、5或7天取样。使用凝血分析仪测量凝血因子II、V、VIII、IX、X和XIII、血管性血友病因子（VWF）和纤维蛋白原。通过校准自动血栓图测量凝血酶生成。
解冻后储存期间FVIII降低；全血（p = 0.0002）和单采（p < 0.0001）在24小时后显著降低。所有单采和20份全血冷沉淀中的8份在解冻后第14天符合FVIII规格（≥ 70 IU/单位）。纤维蛋白原在48小时内保持稳定，各成分在解冻后第14天符合规格。储存期间VWF无显著差异（全血p = 0.1292；单采p = 0.1507）。全血和单采冷沉淀的凝血酶生成滞后时间、内源性凝血酶潜力和达到峰值的时间均有小幅但显著的降低。
虽然冷沉淀中的凝血因子在解冻后储存后有所下降，但解冻后的冷沉淀在冷藏温度下储存7天时符合欧洲委员会的规格。
