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The Journal of Bone and Joint Surgery, Vol 76, Issue 1 3-14, Copyright © 1994 by Journal of Bone and Joint Surgery, Inc
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. Enoxaparin Clinical Trial Group
CW Colwell, TE Spiro, AA Trowbridge, BA Morris, HC Kwaan, JD Blaha, AJ Comerota and VA Skoutakis
Scripps Clinic and Research Foundation, La Jolla, California 92037.
A randomized, parallel-group, open-label clinical trial (the physicians,
patients, and staff were not blinded with regard to the regimen that had
been used) was conducted, between December 1988 and September 1990, to
compare the safety and efficacy of enoxaparin, a low-molecular-weight
heparin, with the safety and efficacy of unfractionated heparin for the
prevention of deep venous thrombosis after elective hip replacement. Six
hundred and ten patients were randomized, and 607 patients received one of
the study medications. The evaluations of efficacy included contrast-media
venography, non-invasive vascular examination, and clinical examination.
Data on efficacy were available for 604 patients, who had been assigned to
one of three treatment groups: thirty milligrams of enoxaparin every twelve
hours (194 patients), forty milligrams of enoxaparin once daily (203
patients), or 5000 units of unfractionated heparin every eight hours (207
patients). All drugs were administered subcutaneously. Dosages were not
adjusted on the basis of the results of coagulation tests or the body
weight of the patient. Treatment was initiated within twenty-four hours
after the operation and continued for a maximum of seven days. The primary
safety outcome was the occurrence of bleeding episodes. An intent-to-treat
patient analysis revealed that deep venous thrombosis occurred in nine (5
per cent) of the 194 patients who received thirty milligrams of enoxaparin
every twelve hours, thirty (15 per cent) of the 203 patients who received
forty milligrams of enoxaparin once daily, and twenty-four (12 per cent) of
the 207 patients who received unfractionated heparin. The rate of deep
venous thrombosis was significantly lower in the group that received thirty
milligrams of enoxaparin every twelve hours than in the group that received
unfractionated heparin (p = 0.03) and in the group that received forty
milligrams of enoxaparin once daily (p = 0.0002). No clinically symptomatic
pulmonary embolism was observed during the treatment or follow-up phase of
this study in the group that received thirty milligrams of enoxaparin every
twelve hours. Analysis of evaluable patients revealed a marked reduction in
the rate of deep venous thrombosis in the group that received thirty
milligrams of enoxaparin every twelve hours (eight [6 per cent] of 136
patients) compared with the group that received heparin (twenty-one [15 per
cent] of 145 patients) (p = 0.10); however, this difference was not
significant because of the small number of patients included in this
analysis.(ABSTRACT TRUNCATED AT 400 WORDS)

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