Defibrotide therapy for thrombophlebitis--controlled clinical trial.

Deep venous thrombosis is a common disease with significant danger of both acute and chronic complications. Widely accepted therapies are based on anticoagulant (heparin and/or anticoagulant agents) or early fibrinolytic therapy. All these therapies frequently have severe side effects. Defibrotide is a new drug with antithrombotic and profibrinolytic activities but without anticoagulant activity and major side effects. To evaluate the efficacy of this drug against acute thrombophlebitis, we treated a group of 10 patients with 200 mg defibrotide intravenously three times a day for 15 days. Fibrinolysis parameters were monitored every other day. The indices of venous function by strain-gauge plethysmography and venous occlusion were evaluated every 7 days. The drug induced a significant improvement in plethysmographic indices and a significant profibrinolytic activity. Defibrotide-treated patients showed a fast disappearance of clinical and instrumental signs of thrombophlebitis. No side effects were reported during the study.