HULL

10-day versus 5-day course of heparin in VTE treatment (1990)

Condition

Treatment of proximal DVT

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Objective

To compare safety and efficacy of a short course heparin with the traditional longer course treatment

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Trial design

Randomized, double-blind study
Active treatment: heparin, i.v. bolus of 5000 IU followed by continuous infusion of 40,000 IU (patients with low bleeding risk) or 30,000 IU (patients with high bleeding risk) per 24 hours over 5 days plus warfarin for 12 weeks started on the first day (10 mg during the first 10 days, then adjusted to INR 2.0–3.0) (n=99)
Control treatment: heparin (same dosing as above) given over 10 days plus warfarin for 12 weeks started on the fifth day (10 mg during the first 5 days, then adjusted to INR 2.0–3.0) (n=100)

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Endpoints

Primary efficacy endpoint: new documented symptomatic VTE during 3-month follow-up
Primary safety endpoints: major and minor bleeding complications during initial heparin treatment

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Trial participants

199 patients with acute proximal DVT documented by venography

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Results

Efficacy outcome: 7 of 99 patients (7.1%) receiving the short course of heparin experienced a symptomatic VTE during the initial phase and the 3-month follow-up period compared to 7 of 100 patients (7.0%) receiving the standard long course
Safety outcome: Hemorrhagic complications occurred in 9 of 99 patients (9.1%) during short-term and in 12 of 100 (12.0%) during long-term heparin treatment. 7 (7.1%) vs. 6 (6.0%) of these complications were major bleeding

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Summary

Efficacy: A 5-day course of heparin is as effective as a 10-day course in preventing symptomatic VTE recurrence in patients with acute proximal DVT
Safety: There was a trend towards less bleeding complications in the short-term heparin group

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Reference

Hull RD, Raskob GE, Rosenbloom D, Panju AA, Brill-Edwards P, Ginsberg JS, Hirsh J, Martin GJ, Green D. Heparin for 5 days as compared with 10 days in the initial treatment of proximal venous thrombosis. N Engl J Med 1990;322:1260-1264

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Corresponding author

Russell D. Hull, MD, University of Calgary, Department of Medicine, Foothills Hospital, 3330 Hospital Dr., N.W., Calgary, AB T2N 4N1, Canada

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