ENOXAPARIN Clinical Trial Group (1)

Enoxaparin vs. unfractionated heparin for the prevention of deep venous thrombosis after hip replacement (1994)

Condition

Prophylaxis for DVT after total hip replacement

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Objective

To compare the efficacy and safety of two dosages of enoxaparin vs. standard heparin for DVT prophylaxis after elective hip surgery

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Trial design

Randomized, open-label study with parallel groups
Active treatment: enoxaparin 30 mg s.c. twice daily (n=195) or enoxaparin 40 mg s.c. once daily (n=205), starting within 24 hours after surgery and continued for 7 days
Control treatment: UFH 5000 IU s.c. every 8 hours, starting within 24 hours after surgery and continued for 7 days (n=210)

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Endpoints

Primary efficacy endpoint: DVT
Primary safety endpoints: major and minor bleeding
Secondary safety endpoints: need for transfusion, hemoglobin level

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Trial participants

610 consecutive patients (mean age 65 years) scheduled for elective total hip replacement; 604 patients were included in the intent-to-treat analysis

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Results

Efficacy outcome: In the intent-to-treat population (n=604), DVT occurred in 9 of 194 patients (4.6%) assigned to 30 mg enoxaparin twice daily, 30 of 203 patients (14.8%) assigned to 40 mg enoxaparin once daily, and 24 of 207 patients treated with UFH (11.6%). The rate of DVT was significantly lower in the group that received 30 mg of enoxaparin every 12 hours than in the group that received UFH (p=0.03) and in the group that received 40 mg of enoxaparin once daily (p=0.0002). The rate was not significantly different between the 40 mg enoxaparin group and the UFH group (p=0.24)
Safety outcome: Major bleeding occurred in 6 patients (4.1%) managed with 30 mg enoxaparin twice daily, 3 patients (0.9%) receiving 40 mg enoxaparin once daily, and 13 patients (6.2%) in the UFH group. The difference between the 40 mg enoxaparin group and the UFH group was statistically significant (p=0.02). The rates of minor bleeding episodes were 8.2%, 8.7%, and 5.7% in the patients given 30 mg enoxaparin twice daily, 40 mg enoxaparin once daily, and UFH, respectively

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Summary

Efficacy: In patients undergoing elective hip replacement, treatment with enoxaparin, administered postoperatively in a dosage of 30 mg twice daily, is more effective than UFH
Safety: The rate of major bleeding episodes was not significantly different between the patients assigned to 30 mg of enoxaparin twice daily and the patients receiving UFH

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Reference

Colwell CW Jr, Spiro TE, Trowbridge AA, Morris BA, Kwaan HC, Blaha JD, Comerota AJ, Skoutakis VA, for the Enoxaparin Clinical Trial Group. Use of enoxaparin, a low-molecular-weight heparin, and unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. A clinical trial comparing efficacy and safety. J Bone Joint Surg 1994;76:3-14

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Corresponding author

Clifford W. Colwell, MD, Scripps Clinic and Research Foundation, 10666 North Torrey Pines Road, La Jolla, California 92037, USA

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