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Thromb Haemost 2000; 83(04): 523-529
DOI: 10.1055/s-0037-1613856
Commentary
Schattauer GmbH

A Comparative, Double-blind, Randomised Trial of a New Second Generation LMWH (Bemiparin) and UFH in the Prevention of Post-operative Venous Thromboembolism

V. V. Kakkar
1   From the Thrombosis Research Institute, Emmanuel Kaye Building, Chelsea, London, UK
,
J. Howes
1   From the Thrombosis Research Institute, Emmanuel Kaye Building, Chelsea, London, UK
,
V. Sharma
1   From the Thrombosis Research Institute, Emmanuel Kaye Building, Chelsea, London, UK
,
Z. Kadziola
1   From the Thrombosis Research Institute, Emmanuel Kaye Building, Chelsea, London, UK
,
the Bemiparin Assessment group › Author AffiliationsThe Bemiparin Collaborative Assessment Group was financially supported by Laboratorios Farmaceuticos Rovi S.A., (Madrid, Spain) who also provided a supply of low-molecular-weight heparin and standard unfractionated sodium heparin. We are grateful to the trial coordinators and clinical and nursing staff from the participating hospitals and Miss Sarah Edwards for secretarial assistance.
Further Information

Publication History

Received 26 May 1999

Accepted after resubmission 24 November 1999

Publication Date:
08 December 2017 (online)

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Summary

A randomised, prospective, double-blind trial was performed, to compare the safety and efficacy of a new low-molecular-weight heparin (LMWH) Bemiparin and standard unfractionated heparin (UFH), for the prophylaxis of postoperative venous thromboembolism. 300 patients scheduled to undergo elective hip arthroplasty were included. The principal outcome measures were the incidence of thromboembolic events and bleeding complications. 149 patients received 3,500 anti-Xa IU of bemiparin plus a placebo injection daily and 149 patients received 5,000 IU of UFH twice a day.

The two groups were similar with respect to factors likely to affect the risk of developing post-operative venous thromboembolism (VTE) and risk of bleeding events. During the post-operative period, 34 patients developed VTE complications; 9 (7.2%) in the bemiparin group and 25 (18.7%) in the UFH group. VTE in the two groups was statistically significant (OR of 2.96; 95% CI 1.32-6.62 and p = 0.01).

There were no significant differences in the frequency of bleeding complications: major bleeding requiring discontinuation of prophylaxis, (OR 1.21; 95% CI 0.36-4.05; p = 1.00), the measured median operative blood loss (p = 0.77) or the median postoperative drain loss (p = 0.97), and the number of patients who developed wound haematoma (OR 0.87; 95% CI 0.31-2.46; p = 1.00).

A comparison of coagulation parameters on the preoperative day with post-operative day 2 ± 1, day 6 ± 1 and day of discharge showed a significantly higher AT concentration, anti-factor Xa activity and TFPI levels in the bemiparin group when compared with UFH.

This study demonstrates that bemiparin, in a single daily subcutaneous dose of 3,500 anti-Xa IU in high risk patients undergoing hip arthroplasty is more effective than UFH administered twice daily at a dose of 5,000 IU in the prevention of postoperative VTE. Both agents are equally safe.

List of participants, their affiliations and current addresses are listed in the appendix on p. 528

Keywords

Heparin - prevention of venous thromboembolism
 

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