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Previous Volume 347:726-730 September 5, 2002 Number 10 Next

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ABSTRACT

Background Deep-vein thrombosis is a well-recognized complication after trauma to the legs and subsequent immobilization, but there are no generally accepted approaches to preventing this complication.

Methods We performed a prospective, double-blind, placebo-controlled trial to evaluate the efficacy and safety of subcutaneous reviparin (1750 anti-Xa units given once daily) in 440 patients who required immobilization in a plaster cast or brace for at least five weeks after a leg fracture or rupture of the Achilles tendon. The study drug was given throughout the period of immobilization. Venography of the injured leg was performed within one week after removal of the plaster cast or brace, or earlier if there were symptoms suggesting deep-vein thrombosis.

Results Data on efficacy and end points were available for 371 patients. Deep-vein thrombosis was diagnosed in 17 of the 183 patients randomly assigned to receive reviparin (9 percent) and in 35 of the 188 patients randomly assigned to receive placebo (19 percent) (odds ratio, 0.45; 95 percent confidence interval, 0.24 to 0.82). Most of the thromboses were distal (14 in the reviparin group and 25 in the placebo group). There were two cases of pulmonary embolism, both in patients in the placebo group who also had proximal deep-vein thrombosis. There were no differences between the two groups with respect to bleeding or other adverse events.

Conclusions Deep-vein thrombosis is common in persons with leg injury requiring prolonged immobilization. Reviparin given once daily appears to be effective and safe in reducing the risk of this complication.

Source Information

From the Department of Orthopedics, Hillerød Hospital, Hillerød, Denmark (M.R.L.); the Department of Orthopedics, Section of Traumatology, Århus University Hospital, Århus, Denmark (L.C.B.); and Knoll, Ludwigshafen, Germany (R.L.N.).

Address reprint requests to Dr. Lassen at the Department of Orthopedics, Hillerød Hospital, Helsevej 2, DK-3400 Hillerød, Denmark, or at mirula{at}fa.dk.

Full Text of this Article

Related Letters:

Reviparin after Leg Injury Requiring Immobilization
Jersmann H. P.A., Girard P., Murashige N., Kami M., Takaue Y., Lassen M. R., Borris L. C., Nakov R. L.
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N Engl J Med 2003; 348:1061-1063, Mar 13, 2003. Correspondence

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