Pathophysiology of Haemostasis and Thrombosis

Clinical Profile

Effectiveness of Defibrotide for Prophylaxis of Deep Venous Thrombosis in Gynecological Surgery: A Double-Blind, Placebo-Controlled Clinical Trial

Ciavarella N.a · Ettorre C.a · Schiavoni M.a · Schonauer S.b · Cicinelli E.b · Cagnazzo G.b

Author affiliations

aBlood Coagulation Service, and bFirst Gynecological and Obstetric Department, University Hospital, Bari, Italy

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Haemostasis 1986;16:39–41

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Article / Publication Details

First-Page Preview
Abstract of Clinical Profile

Published online: October 25, 2010
Issue release date: 1986

Number of Print Pages: 3
Number of Figures: 0
Number of Tables: 0

ISSN: 1424-8832 (Print)
eISSN: 1424-8840 (Online)

For additional information: https://www.karger.com/PHT

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 < 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.

© 1986 S. Karger AG, Basel




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Article / Publication Details

First-Page Preview
Abstract of Clinical Profile

Published online: October 25, 2010
Issue release date: 1986

Number of Print Pages: 3
Number of Figures: 0
Number of Tables: 0

ISSN: 1424-8832 (Print)
eISSN: 1424-8840 (Online)

For additional information: https://www.karger.com/PHT


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