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document
Subcutaneous low-molecular-weight heparin compared with continuous intravenous unfractionated heparin in the treatment of proximal deep vein thrombosis . BACKGROUND A low-molecular-weight heparin , enoxaparin sodium , has been shown to be effective and safe in preventing deep vein thrombosis both in general surgery and in high-risk orthopedic surgery . We conducted a controlled , randomized trial with enoxaparin in the treatment of established deep vein thrombosis . METHODS In a multicenter trial , we compared fixed-dose subcutaneous enoxaparin , given twice daily , with adjusted-dose intravenous unfractionated heparin ( UFH ) given by continuous intravenous infusion for the initial 10 days of treatment of patients with proximal vein thrombosis . The primary efficacy outcome was the change of the size of the thrombus assessed by repeated venograms between day 0 and day 10 . The primary analysis of safety was based on the incidence of major bleeding during 10 days of treatment . RESULTS There were 67 patients in each group . Venographic assessment of clot size evolution between day 0 and day 10 showed a statistically significant superiority ( P < .002 ) of enoxaparin over the reference treatment with UFH . Moreover , the incidence of overall recurrent thromboembolic events during 10 days of treatment was significantly higher ( P < .002 ) in the UFH group ( seven of 67 ) than in the enoxaparin group ( one of 67 ) . There were no serious bleeding complications in either group . CONCLUSIONS Enoxaparin is at least as effective and safe as UFH under the conditions of this study . Moreover , it is more comfortable for patients and less time-consuming for nurses and laboratories . Thus , our study confirmed , with the use of enoxaparin , other observations that low-molecular-weight heparin provides a real therapeutic advance in the treatment of deep vein thrombosis .
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Intervention_Pharmacological
low-molecular-weight heparin
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Intervention_Pharmacological
unfractionated heparin
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Intervention_Pharmacological
low-molecular-weight heparin
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Intervention_Pharmacological
enoxaparin sodium
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
unfractionated heparin ( UFH )
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
UFH
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Intervention_Pharmacological
UFH
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
Enoxaparin
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Intervention_Pharmacological
UFH
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
low-molecular-weight heparin
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Outcome_Physical
change of the size of the thrombus
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Outcome_Adverse-effects
incidence of major bleeding
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Outcome_Physical
clot size evolution
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Outcome_Adverse-effects
incidence of overall recurrent thromboembolic events
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Outcome_Adverse-effects
serious bleeding complications
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Participant_Condition
proximal deep vein thrombosis
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Participant_Condition
deep vein thrombosis
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Participant_Condition
proximal vein thrombosis
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Participant_Sample-size
67
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Participant_Condition
deep vein thrombosis