Effectiveness of defibrotide for prophylaxis of deep venous thrombosis in gynecological surgery: a double-blind, placebo-controlled clinical trial

Haemostasis
N CiavarellaG Cagnazzo

Abstract

Defibrotide, a new antithrombotic compound without anticoagulant activity, has been tested for prevention of deep venous thrombosis (DVT) in patients undergoing gynecological surgery (mainly hysterectomy). Eighty-nine women (mean age 48.5) were randomly allocated to defibrotide (44 patients) or placebo (45 patients). 800 mg defibrotide was given daily (200 mg intravenously 4 times a day), starting on the day before operation and then for the next 7 days. DVT were detected by the conventional 125I-fibrinogen test. The two groups were homogeneous for known risk factors (age, varicosities, obesity, neoplasia and previous thromboembolic episodes). The results showed a statistically significant reduction of DVT incidence in patients on defibrotide, as compared with those on placebo: 4/44 = 9% vs. 13/45 = 28.8% (p less than 0.05). There were no side effects, including hemorrhagic complications. The numbers of units transfused were comparable for the 2 groups. In conclusion, the trial shows that defibrotide is an effective and safe drug for the prevention of DVT in gynecological surgery.

Citations

Jan 1, 1989·European Journal of Clinical Pharmacology·T Di PerriL Ceccatelli
Jul 11, 2008·Expert Opinion on Biological Therapy·A LaroccaA Palumbo
May 22, 2009·Expert Opinion on Biological Therapy·F MorabitoA Palumbo
Dec 12, 2012·Expert Opinion on Drug Safety·Paul G RichardsonRobert Soiffer
Apr 23, 2020·Frontiers in Immunology·Francesca BonifaziAntonio Colecchia

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