A biochemical quality study of a pharmaceutically licenced coagulation active plasma (Octaplas(R)) thawed by the SAHARA-III dry tempering system compared to the regular use of a water bath.

摘要

Background and Objectives 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(R), thawed using the SAHARA-III dry tempering system from the company Sarstedt GmbH, Austria. A regular water bath was used in parallel for comparison. Materials and Methods Six batches Octaplas(R) 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. Results There were neither significant differences in the blood coagulation parameters, coagulation factors, protease inhibitors, nor of markers of activated coagulation and fibrinolysis when Octaplas(R) 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. Conclusion Octaplas(R) 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(R) in the emergency unit or operating theatre, where no water baths can be utilized, is safe and can be fully endorsed.