Prevention of Deep Vein Thrombosis after Major Knee Surgery - A Randomized, Double-Blind Trial Comparing a Low Molecular Weight Heparin Fragment (Enoxaparin) to Placebo

Jacques R Leclerc; William H Geerts; Louis Desjardins; François Jobin; François Laroche; Fernand Delorme; Sylvie Haviernick; Susan Atkinson; Jean Bourgouine

doi:10.1055/s-0038-1648463

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1992; 67(04): 417-423
DOI: 10.1055/s-0038-1648463

Original Articles

Schattauer GmbH Stuttgart

Prevention of Deep Vein Thrombosis after Major Knee Surgery - A Randomized, Double-Blind Trial Comparing a Low Molecular Weight Heparin Fragment (Enoxaparin) to Placebo

Jacques R Leclerc

¹The Department of Medicine and Clinical Epidemiology Unit, Montreal General Hospital, McGill University, Montreal, Canada

,

William H Geerts

²Department of Medicine and Clinical Epidemiology Unit, Sunnybrook Health Science Centre, University of Toronto, Toronto, Canada

,

Louis Desjardins

³Division of Hematology, Centre Hospitalier de I’Université Laval, Université Laval, Quebec, Canada

,

François Jobin

⁴Division of Hematology, Hopital du St-Sacrement, Université Laval, Quebec, Canada

,

François Laroche

⁵Division of Radiology, Hôpital du St-Sacrement, Universite Laval, Quebec, Canada

,

Fernand Delorme

⁶Department of Pathology, Universite de Montréal, Montreal, Canada

,

Sylvie Haviernick

⁷Division of Clinical Research, Rhône-Poulenc Rorer, Montreal, Canada

,

Susan Atkinson

⁸Division of Hematology, Montreal General Hôspital, Me Gill University, Montreal, Canada

,

Jean Bourgouine

⁹Division of Pharmacology, Universite de Montreal, Montreal, Canada

› Author Affiliations

Abstract

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Summary

Consecutive patients undergoing knee arthroplasty or tibial osteotomy at four participating hospitals received either enoxaparin, 30 mg subcutaneously every 12 h (n = 66) or an identicalappearing placebo (n = 65). All study medications started the morning after the operation and were continued up to a maximum of 14 days. Patients underwent surveillance with ¹²⁵I-fibrinogen leg scanning and impedance plethysmography. Bilateral contrast venography was performed routinely at Day 14 or at time of discharge, if sooner. Deep vein thrombosis was detected by venography in 35 of 54 patients (65%) in the placebo group and in 8 of 41 patients in the enoxaparin group (19%), a risk reduction of 71%, P <0.0001. For the entire study group, deep vein thrombosis was detected by either venography of non-invasive tests in 37 of 64 patients (58%) in the placebo group and in 11 of 65 patients (17%) in the enoxaparin group, a risk reduction of 71%, P <0.0001. Proximal vein thrombosis was found in 19% of the placebo patients and in none of the enoxaparin patients, a risk reduction of 100%, P <0.001. Bleeding complications occurred in 5 of 65 patients (8%) in the placebo group and in 4 of 66 patients (6%) in the enoxaparin group, P = 0.71. There were no differences in the amount of blood loss, minimum hemoglobin levels and number of units of packed red cells given between the two treatment groups. We conclude that a fixed dose regimen of enoxaparin, started post-operatively, is an effective and safe regimen for reducing the frequency of deep vein thrombosis after major knee surgery.

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References

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