TASMAN Study Group

Treatment of proximal DVT with low-molecular-weight heparin at home vs. standard
heparin in hospital (1996)

Condition

Treatment of acute proximal DVT in outpatients

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Objective

To compare the efficacy and safety of adjusted-dose intravenous standard heparin given in hospital with those of fixed-dose subcutaneous low-molecular-weight heparin given at home in patients with proximal DVT and to confirm through quality-of-life assessments that home treatment had no adverse effects on patients’ well-being

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Trial design

Randomized, open study with parallel groups
Active treatment: nadroparin s.c. twice daily adjusted for the patient’s weight: 8200, 12,300, or 18,400 anti factor Xa IU/L per day in patients weighing <50, 50–70, or >70 kg, respectively, given for at least 5 days and until the concomitant oral anticoagulant therapy resulted in an INR >2.0. As soon as appropriate, patients were allowed to be treated at home (n=202)
Control treatment: UFH 5000 IU i.v. bolus, then ≥1250 IU/h continuous i.v. infusion to target aPTT 1.5–2.0 times a control value, for ≥5 days until INR >2.0. The patients were treated in hospital (n=198)
Quality-of-live assessment: Patients completed disease-specific questionnaires before randomization, after initial treatment, and 12 and 24 weeks after randomization

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Endpoints

Primary efficacy endpoint: recurrent VTE during 6-month follow-up
Secondary endpoints: major bleeding during the first 3 months; quality of life

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Trial participants

400 consecutive symptomatic outpatients with documented acute proximal DVT but no signs of PE

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Results

Efficacy outcome: 17 of the 198 patients receiving standard heparin (8.6%) and 14 of the 202 patients assigned to nadroparin (6.9%) had recurrent VTE during the 6-month follow-up
Safety outcome: At 3 months, major bleeding occurred in 4 patients in the UFH group (2.0%) and in 1 patient in the nadroparin group (0.5%). 16 (8,1%) patients in the standard-heparin group and 14 (6.9%) patients in the nadroparin group died during the 6-months study period. No patient died during the initial treatment
Quality of life: Quality of life improved in both groups. Physical activity and social functioning were better in the patients assigned to nadroparin. Among the patients in that group, 36% were never admitted to the hospital at all, and 40% were discharged early. This treatment was associated with a mean reduction in hospital days of 67%

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Summary

Efficacy: Nadroparin was least as effective as standard heparin but permits approximately 75% of patients with proximal DVT to be treated as outpatients or discharged early from the hospital
Safety: Rates of major bleeding were both low and similar in the two treatment groups
Quality of life: Home treatment with nadroparin improved physical and mental well-being more than in-hospital treatment with standard heparin

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Reference

Koopman MM, Prandoni P, Piovella F, Ockelford PA, Brandjes DP, van der Meer J, Gallus AS, Simonneau G, Chesterman CH, Prins MH. Bossuyt PMM, de Haes H, van den Belt AGM, Sagnard L, D’Azemar P, Büller HR, for the Tasman Study Group. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. N Engl J Med 1996;334:682-687

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Corresponding author

Maria M.W. Koopman, MD, Academic Medical Center, University of Amsterdam, Center for Hemostasis, Thrombosis, Atherosclerosis, and Inflammation Research, Rm. F4-133, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands

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