Search

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., (Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.)

Introduction: Many transfusion services are keeping thawed plasma (TP) ready for trauma patients. According to Chinese guidelines, once thawed, fresh frozen plasma (FFP) should be used within 24h. This may increase plasma wastage and delay plasma administration to critical patients. However, it can be avoided by being relabeled as TP. In this study we evaluated coagulation-related proteins in thawed apheresis FFP during 5 days of storage at 1-6 °C., Materials and Methods: Thirty apheresis fresh plasma units were aliquot and stored at -70 °C. Aliquots were thawed at 37 °C and stored at 1-6 °C for 0, 1, 2, 3, 4 and 5 days, respectively. Prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin time (TT), fibrinogen (Fbg), factor (F) II, FV, FVII, FVIII, FIX, FX, FXI, FXII, protein C (PC), protein S (PS), antithrombin III (ATIII) and ADAMTS13 levels were assessed at Days 0-5, respectively., Results: For 5 days of refrigerated storage, no significant differences were observed in Fbg, PC, PS, ATIII and ADAMTS13. FII, FV, FVII, FVIII, FIX, FX, FXI and FXII declined significantly over time. The storage presented major decrease for FVIII, with a drop of 40%. However, at least 60% levels of all measured proteins were remained on Day 5, when compared to Day 0., Conclusion: All measured proteins in TP for 5 days of refrigerated storage were adequate. These could provide evidence that thawed FFP could be relabeled as TP, which is a potential to ensure rapid plasma availability in emergency situations in China., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

In order to increase the yield of prothrombin complex concentrates (PCCs) and to reduce their associated thrombotic risks, the influence of washing conditions on the yield, purity, and balance of coagulation factors (FII, FVII, FIX, and FX), and inhibitor proteins (PC, PS, PZ, and AT [antithrombin]) in PCCs was investigated by orthogonal testing, in which three variables (sodium citrate, NaCl, and pH) and their three levels were selected. It was found that AT yield and purity were extraordinarily low, and at lower NaCl content, the general yield, purity, and balance were higher, lower, and better, respectively; however, the results became contrary at higher NaCl. Moreover, within the investigated levels, NaCl was the first determinant for the yield except AT and the purity except FVII, PC, PS, and AT. Sodium citrate was the first determinant for AT yield and FVII, PS, and AT purity. The yield except FII, PS, and AT decreased and the purity except PC increased with increase of sodium citrate content. Just for PC purity, pH was the first determinant. The effect with pH fluctuation on the yield and purity was characteristically unobvious. The outcome undoubtedly supplies the guidance to further improve PCCs.