Safety of vapour heated prothrombin complex concentrate (PCC) Prothromplex S-TIM 4.

The risk of infection after application of vapour heated prothrombin complex concentrate PROTHROMPLEX S-TIM 4 (PCC) was investigated in patients undergoing cardiovascular surgery. The study was conducted according to the recommendations of the International Committee on Thrombosis and Hemostasis (ICTH) with the exception that most patients required other blood products in addition to PCC. Twenty-One patients were eligible to test for the risk of acquiring hepatitis NANB (ALT-levels) and samples from 12 patients were available that could be screened for anti-HCV. Twenty patients qualified for evaluation of the risk of developing hepatitis B, and 67 patients qualified to test for HIV-1-Infection. None of these patients showed any signs of infection. Vapour heating of prothrombin complex concentrate seems to lower the risk of transmitting viral diseases considerably.