Heger A, Römisch J, Svae T-E
Octapharma Pharmazeutika Produktionsges.m.b.H, Pre-Clinical Research & Development Department, Oberlaaer Strasse 235, A-1100 Vienna, Austria.
Vox Sang. 2008 Jan;94(1):48-55. doi: 10.1111/j.1423-0410.2007.00993.x. Epub 2007 Nov 16.
The most common way to thaw frozen coagulation-active plasma products for transfusion is the use of a water bath with good circulation at 30-37 degrees C. The aim of this study was to perform an extensive biochemical characterization of the pharmaceutically licenced solvent/detergent-treated plasma, Octaplas, thawed using the SAHARA-III dry tempering system from the company Sarstedt GmbH, Austria. A regular water bath was used in parallel for comparison.
Six batches Octaplas with different blood groups were thawed in a water bath or using the SAHARA-III dry tempering system in parallel. Thawed plasma was investigated on screening tests for blood coagulation, as well as on the activities of important coagulation factors and protease inhibitors. In addition, markers of activated coagulation and fibrinolysis were tested and von Willebrand factor multimeric analysis was performed.
There were neither significant differences in the blood coagulation parameters, coagulation factors, protease inhibitors, nor of markers of activated coagulation and fibrinolysis when Octaplas thawed by the two different methods was tested. The von Willebrand factor analyses showed no influence on the overall profile of the multimeric pattern when using the SAHARA-III dry tempering system.
Octaplas can be thawed using the SAHARA-III dry tempering system without any negative influences on the demonstrated quality of this product. The SAHARA-III dry tempering system enables standardized thawing and warming procedure. Furthermore, tempering of Octaplas in the emergency unit or operating theatre, where no water baths can be utilized, is safe and can be fully endorsed.
解冻用于输血的冷冻凝血活性血浆制品最常用的方法是使用温度在30 - 37摄氏度、循环良好的水浴。本研究的目的是对经药物许可的溶剂/去污剂处理的血浆Octaplas进行广泛的生化特性分析，该血浆使用奥地利Sarstedt GmbH公司的SAHARA - III干式回火系统解冻。同时使用常规水浴进行比较。
六批不同血型的Octaplas分别在水浴中或同时使用SAHARA - III干式回火系统解冻。对解冻后的血浆进行凝血筛查试验，以及重要凝血因子和蛋白酶抑制剂活性的检测。此外，检测活化凝血和纤维蛋白溶解的标志物，并进行血管性血友病因子多聚体分析。
对两种不同方法解冻的Octaplas进行检测时，凝血参数、凝血因子、蛋白酶抑制剂以及活化凝血和纤维蛋白溶解标志物均无显著差异。血管性血友病因子分析表明，使用SAHARA - III干式回火系统对多聚体模式的整体分布没有影响。
Octaplas可以使用SAHARA - III干式回火系统解冻，且对该产品已证明的质量没有任何负面影响。SAHARA - III干式回火系统能够实现标准化的解冻和升温程序。此外，在无法使用水浴的急诊室或手术室对Octaplas进行回火是安全的，并且完全值得认可。
