Biochemical characterization of prothrombin complex concentrates in China

Abstract

Despite increasing use of prothrombin complex concentrates (PCCs), there is little knowledge about the biochemical characterization of Chinese PCCs. Six Chinese PCCs were investigated and compared with PCCs (Octaplex®) from Europe. The levels of coagulation factors and inhibitors were detected. The presence of activated coagulation factors was assessed. Furthermore, their thrombin inhibitory capacities, specific activity and purity were assayed. All above parameters of biochemical properties were statistically analyzed. Chinese PCCs contained FⅡ, Ⅶ, Ⅸ and Ⅹ, protein C, S and Z, heparin and extremely low level antithrombin, as well as Octaplex®. The measured FⅨ activities were similar to those declared, however the measured potency of FⅡ, Ⅶ and Ⅹ greatly exceeded the labeled. Though all preparations were negative for activated coagulation factors in non-activated partial thromboplastin time test, the activated coagulation factor Ⅶ (FⅦa) remained in all PCCs and its content differed greatly. Overall, FⅦa content of Chinese PCCs was higher than that of Octaplex®. Further, Chinese PCCs were inferior to Octaplex® in the thrombin inhibitory capacities, specific activity and purity. In summary, compared with Octaplex®, Chinese PCCs' errors about the labeled activity of coagulation factors and probably high risks of thrombosis should be considered.

Keywords: Coagulation factor; Coagulation inhibitor; Prothrombin complex concentrates; Specific activity; Thrombin inhibitory capacity; Thrombotic risk.