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Thromb Haemost 1992; 67(02): 203-208
DOI: 10.1055/s-0038-1648413
Original Articles
Schattauer GmbH Stuttgart

A Randomised, Double-Blind, Placebo-Controlled Trial of Dermatan Sulphate for Prevention of Deep Vein Thrombosis in Hip Fracture

Giancarlo Agnelli
1   The istituto di Semeiotica Medica, Perugia, Italy
,
Benilde Cosmi
1   The istituto di Semeiotica Medica, Perugia, Italy
,
Paolo Di Filippo
2   Istituto di Ortopedia e Traumatologia, Perugia, Italy
,
Valeria Ranucci
1   The istituto di Semeiotica Medica, Perugia, Italy
,
Franca Veschi
1   The istituto di Semeiotica Medica, Perugia, Italy
,
Mauro Longetti
1   The istituto di Semeiotica Medica, Perugia, Italy
,
Cinzia Renga
1   The istituto di Semeiotica Medica, Perugia, Italy
,
Francesco Barzi
3   Istituto di Radiologia, Università di Perugia, Perugia, Italy
,
Francesco Gianese
4   Medical Department, Mediolanum Farmaceutici, Milan, Italy
,
Luciano Lupattelli
3   Istituto di Radiologia, Università di Perugia, Perugia, Italy
,
Emanuele Rinonapoli
2   Istituto di Ortopedia e Traumatologia, Perugia, Italy
,
Giuseppe G Nenci
1   The istituto di Semeiotica Medica, Perugia, Italy
› Author Affiliations
Further Information

Publication History

Received 25 June 1991

Accepted after revision 09 September 1991

Publication Date:
02 July 2018 (online)

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Summary

Dermatan sulphate (MF 701) is a natural glycosaminoglycan that catalyses thrombin inhibition by heparin cofactor II. The aim of the study was to evaluate the efficacy and safety of MF 701 for prevention of deep vein thrombosis (DVT) in patients with hip fracture. A randomised, double-blind, placebo-controlled design was used to assess two dose regimens of MF 701 in two consecutive study phases. Treatment was started within 48 h from the trauma and continued for 14 days for non-operated patients or until the 10th postoperative day. Bilateral mandatory venography was used to assess the end-point. Eighty patients were included in the first phase (40 MF 701, 40 placebo). MF 701, 100 mg IM b. i. d., did not reduce incidence of DVT from that on placebo and did not induce any bleeding. In the second phase 126 patients were included, with a randomisation ratio of 2:1 (84 MF 701, 300 mg IM b.i.d., 42 placebo). Bilateral venography was obtained for 110 patients. The incidence of DVT was 64% (23/36) in the placebo group and 38% (28/74) in the MF 701 group (p = 0.01; odds ratio [OR] = 0.34, 95% confidence limits [CL] = 0.15-0.80); proximal DVTs were 42% (15/36) and 20% (15/74), respectively (p = 0.02; OR = 0.36, CL = 0.15-0.89). No significant differences were found in haemorrhagic complications (2.4% in each group), blood loss from drains, blood transfusions, haemoglobin and haematocrit values. This study is the first demonstration that dermatan sulphate is a clinically effective antithrombotic agent without bleeding effects. It also provides evidence of the biological role of heparin cofactor II.

 

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