Hematology Laboratory-Blood Bank, Aretaieion Hospital, National and Kapodistrian University of Athens, Athens, Greece.
National Blood Transfusion Centre, Athens, Greece.
Transfusion. 2022 Nov;62(11):2188-2193. doi: 10.1111/trf.17115. Epub 2022 Sep 19.
Although there are guidelines on industrial manufacture of plasma-derived medicinal products, there are no clear recommendations about plasma intended for fractionation, as there is no expiry time and the effect of prolonged storage on the activity of coagulation factors is unknown.
A total of 237 units of plasma stored at -30°C in the National Blood Transfusion Centre for 1 year (62 units), 5 years (75 units), and 10 years (100 units) were studied. The effect of storage time was investigated by determining the activity of clotting factors FII, FV, FVII, FVIII, FIX, FX, FXI, FXII, FXIII using coagulometric methods and antithrombin III and fibrinogen with chromogenic assays, using System BCS > XP (Siemens Healthcare diagnostics Marburg, Germany). Albumin was measured by Medilyzer (BX, Medicon). ABO blood group was recorded and correlated with the levels of FVIII. Comparison of values between one and five, 1 and 10 and 5 and 10 years of storage was performed via the SAS for Windows 9.4 software platform (SAS Institute Inc., NC, U.S.A.).
Albumin, AT III, fibrinogen, FIX, FXI, FXII, and FXIII remain rather stable even after 10 years of storage. Levels of FII, FV, FVII, FVIII, and FX decreased after 5 years of storage.
Our study is in agreement with all the previous studies and concludes that there is a putative usability of recovered plasma and some of its coagulation factors after many years of storage at the recommended temperature.
尽管有关于血浆衍生药物制品工业生产的指南，但对于用于分离的血浆，由于没有失效时间，并且延长储存对凝血因子活性的影响尚不清楚，因此没有明确的建议。
共研究了 237 单位在国家血液中心于-30°C 储存 1 年（62 个单位）、5 年（75 个单位）和 10 年（100 个单位）的血浆。通过使用凝固法测定凝血因子 FII、FV、FVII、FVIII、FIX、FX、FXI、FXII、FXIII 的活性，以及使用发色测定法测定抗凝血酶 III 和纤维蛋白原，来研究储存时间的影响，使用 System BCS > XP（德国西门子医疗诊断马堡）。白蛋白用 Medilyzer（BX，Medicon）测量。记录 ABO 血型并与 FVIII 水平相关联。通过 SAS for Windows 9.4 软件平台（SAS Institute Inc.，NC，USA）对 1 年与 5 年、1 年与 10 年和 5 年与 10 年储存之间的数值进行比较。
即使在储存 10 年后，白蛋白、AT III、纤维蛋白原、FIX、FXI、FXII 和 FXIII 仍相当稳定。在储存 5 年后，FII、FV、FVII、FVIII 和 FX 的水平下降。
我们的研究与所有先前的研究一致，得出的结论是，在推荐的温度下储存多年后，回收的血浆及其一些凝血因子仍有潜在的可用性。
