PLANES

Enoxaparin vs. unfractionated heparin in patients undergoing total hip replacement (1988)

Condition

Prophylaxis for VTE after total hip replacement

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Objective

To compare the efficacy and safety of enoxaparin and standard heparin for VTE prophylaxis after elective hip surgery

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Trial design

Randomized, double-blind, placebo-controlled study
Active treatment: enoxaparin 40 mg s.c. 12 hours before surgery and then once daily for 14 days or until hospital discharge; UFH placebo (n=124)
Control treatment: UFH 5000 IU s.c. 2 hours before surgery and then 8 hourly for 14 days or until hospital discharge; enoxaparin placebo (n=113)

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Endpoints

Primary efficacy endpoint: venous thrombosis
Primary safety endpoints: major and minor bleeding
Secondary endpoints: number of units of blood transfused during and after surgery, hemoglobin level

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Trial participants

237 consecutive patients aged ≥45 years, scheduled for elective total hip replacement

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Results

Efficacy outcome: The efficacy analysis was based on 120 patients assigned to enoxaparin and 108 patients assigned to UFH. In the enoxaparin group, DVT was detected in 15 patients (12.5%), as compared with 27 patients (25%) in the UFH group. Proximal DVT occurred in 7.5% and 18.5%, respectively. The differences between groups were statistically significant (p=0.03 and p=0.014, respectively)
Safety outcome: The safety analysis was performed in 124 patients assigned to enoxaparin and 112 patients assigned to UFH. Major bleeding occurred in 2 patients treated with enoxaparin, minor bleeding developed in 1 patient given enoxaparin and in 2 patients given UFH. Patients in the enoxaparin group required fewer red blood cell transfusions after surgery (0.66 vs. 1.09 units) and had significantly higher hemoglobin levels on postoperative day 3 and 4 (12.524 vs. 11.993 g/100 ml; p=0.039)

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Summary

Efficacy: In patients undergoing elective hip replacement who have a high risk for both thrombosis and bleeding, treatment with once daily enoxaparin resulted in a significantly lower incidence of total and proximal DVT than treatment with 3-times daily UFH
Safety: The rates of bleeding were low in both groups and were not statistically different. In patients receiving UFH, the red cell transfusion requirements and the fall in hemoglobin were significantly greater, as compared with patients assigned to enoxaparin

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Reference

Planes A, Vochelle N, Mazas F, Mansat C, Zucman J, Landais A, Pascariello JC, Weill D, Butel J. Prevention of postoperative venous thrombosis: a randomized trial comparing unfractionated heparin with low molecular weight heparin in patients undergoing total hip replacement. Thromb Haemost 1988;60:407-410

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Corresponding author

André Planes, MD, Clinique Radio-Chirurgicale du Mail, 96, Allées du Mail, 17028 La Rochelle Cedex, France

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