OBJECTIVES: To assess morbidity and mortality in patients treated with Refludan for heparin-induced thrombocytopenia type II in comparison with controls. PATIENTS AND METHODS: One hundred thirteen patients with heparin-induced thrombocytopenia were treated with Refludan in two studies, HAT1 and HAT2. Clinical outcome was assessed in a meta analysis and compared to results in 91 control patients from a former series. Patients with no associated thrombolytic treatment were given an intravenous bolus injection of Refludan (0.4 mg/kg) then a continuous infusion of Refuldan (0.15 mg/kg/h). When a thrombolytic treatment was associated, patient were given a 0.2 mg/kg) bolus followed by a 0.10 mg/kg/h infusion. RESULTS: The rate of thromboembolism complications, amputations and death was significantly lower in patients treated with Refludan than in controls. There was a clinically acceptable increase in episodes of bleeding with Refludan. The benefit/risk ratio was optimum for APTT between 1.5 and 3.