Effectiveness of defibrotide for prophylaxis of deep venous thrombosis after general surgery: a double-blind, placebo-controlled clinical trial.

Abstract

The prophylactic activity of defibrotide, a new extractive antithrombotic-thrombolytic agent of mammalian origin, was assessed by detection of deep venous thrombosis (DVT) in patients who underwent general elective surgery. 120 patients (aged 25-85 years, mean 55.6) were randomly assigned to defibrotide (60 patients) or to placebo (60 patients). The two groups were homogeneous for age, sex and risk factors for DVT. The active drug was given intravenously 200 mg four times a day, starting the day before the operation and then for the following 7 days. To detect DVT, 125I-fibrinogen was used, by conventional methods. Defibrotide reduced the frequency of DVT to 4/60 (7%) from 16/60 (27%) in the placebo group. The difference was highly significant (p less than 0.01). Neither side effects nor anticoagulant activity were observed. On the basis of this evidence, defibrotide may be considered an effective and well-tolerated drug for prevention of DVT.