[An open study on the efficacy and tolerance of a low molecular weight heparin (CY 216) in the therapeutic treatment of deep venous thrombi in orthopedics].

A prospective clinical trial was performed to evaluate the efficacy and safety of a low molecular weight heparin (nadroparine, CY 216) in the treatment of patients with deep venous thrombosis following recent orthopaedic surgery or trauma. Forty-three patients received nadroparine subcutaneously, 100 IU AXa.kg-1 every 12 hours for a period of 10 days. A quantitative assessment of deep vein thrombosis was made according Marder's scoring after 10 days of treatment. A substantial lysis was observed in 73 per cent and a revascularisation in 52 per cent of the patients. These results are statistically significant, although not correlated with the clinical symptoms and the size of the thrombi. Tolerance was assessed on the rate of bleeding events: a minor bleeding occurred in 6 per cent of the patients. Laboratory adjustment was performed in 8 per cent of the cases. The results of this study suggest that nadroparine administered subcutaneously at a fixed daily dose of 200 IU AXa.kg-1 is as efficient and safe as unfractionated heparin in the treatment of early venous thrombosis following orthopaedic surgery or trauma.