[Quality control of prothrombin complex preparations: in vivo and in vitro findings]

Prothrombin complex concentrates (PCC) are frequently used for the treatment of acquired coagulation factor deficiencies. However, a major problem when using these preparations is their thrombogenic potential. Thus, the potency and tests for thrombogenicity were studied prospectively in 7 different PCC's. Human albumine and a factor IX concentrate served as controls. The potency of coagulation factors and inhibitors varied considerably, especially for proteins S and C. Two preparations exhibited high amidolytic activities in vitro. These activities could be quenched in part by the addition of hirudin or antithrombin III. Additionally, these two preparations caused more severe cardiopulmonary reactions in rabbits and an increase of fibrin split products. We conclude that the use of these preparations in patients, in whom an acquired protein C or S defect, or a hypercoagulable state, can be suspected, cannot be recommended.