Recombinant hirudin (HBW 023): Biological data of ten patients with severe venous thrombo‐embolism

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Abstract
This study reports on the biological data of ten patients with acute venous thromboembolism. They were treated for 5 days with continuous intravenous infusion of a fixed dose (0.05 mg/kg/hr) of a recombinant hirudin (r‐H HBW 023 Behringwerke, Germany). The plasma level of r‐H (HBW 023), assessed by an anti‐factor Ila amidolytic activity, was stable after Day 2 and showed considerable individual variations. It correlated with APTT ratio, suggesting that this test is a reliable tool to monitor therapy. In contrast, thrombin time was constantly over 120 sec (control 15 sec) and consequently was not a useful parameter. Prothrombin time showed a slight, but significant, prolongation, which was correlated with the increase of APTT ratio. There was no bleeding time prolongation, platelet count, or ATIII level decrease. Levels of thrombin‐antithrombin III complexes, and D‐dimers, which were high in all patients on admission, decreased during the course of the treatment but remained abnormal on Day 5, showing an ongoing hemostasis and fibrinolysis activation: this is consistent with the delayed, but only slightly decreased thrombin generation evidenced by thrombin generation test performed on Day 3. These results suggest that thrombin inhibition by rH‐hirudin at this dosage is only partial, which allows the generation of traces of thrombin needed for the feed‐back thrombin production generated by factor V and VIII activation. © 1995 Wiley‐Llss, Inc.