HAT3 Study

The third prospective trial, HAT-3, was the largest and involved 205 patients: 98 patients were assigned to dose regimen A1, 12 to regimen A2, and 84 to regimen B (Lubenow et al., 2005). Ten patients received lepirudin for CPB (regimen C), and one received lepirudin by the sc route. Seventeen patients received more than one treatment cycle. For the efficacy parameters only the first treatment cycle was calculated. For safety analysis, especially allergic reactions, all treatment cycles were included.

All 110 patients in treatment groups A1 and A2 had developed at least one thromboembolic complication (TEC) before the start of lepirudin treatment. The ratio of venous: arterial thrombosis in this patient group was 12:1. The median duration of treatment across all treatment arms was 10.0 days: A1, 9 days (1-197); A2, 12 days (5-21); B, 10 days (1-47); and C (followed by regimen B post-CPB surgery), 7 days (1-37). Mean lepirudin doses were 0.11, 0.08, and 0.07 mg/kg/h in groups A1, A2, and B, respectively. During the study, phenprocoumon was given to 121 (59%) patients.

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