GALILEI Investigators

Adjusted-dose unfractionated heparin vs. fixed-dose low-molecular-weight heparin in the initial treatment of VTE (2004)

Condition

Treatment of acute symptomatic VTE, including recurrent VTE and PE

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Objective

To determine whether the subcutaneous administration of UFH with the use of aPTT-adjusted doses according to a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE

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Trial design

Randomized, open trial with parallel groups
Active treatment: UFH i.v. bolus followed by s.c. injection in doses adjusted to body weight (targeted aPTT range 50–90 s): 4000 IU i.v. plus 12,500 IU s.c. in patients weighing <50 kg; 5000 IU plus 15,000 IU, in patients weighing 50–70 kg; and 6000 IU plus 17,500 IU in patients weighing >70 kg. UFH was administered for ≥5 days and until the concomitant treatment with warfarin resulted in an INR >2.0 (n=360)
Control treatment: nadroparin 85 IU/kg s.c. twice daily for ≥5 days until INR >2.0 (n=360)

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Endpoints

Primary efficacy endpoint: recurrent VTE during the initial treatment period and 3-month follow-up
Primary safety endpoints: major bleeding during the initial treatment period and death during 3-month follow-up

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Trial participants

720 consecutive patients with acute symptomatic VTE, including 119 non-critically ill patients with PE and 102 with recurrent VTE

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Results

Efficacy outcome: Among the 360 patients assigned to UFH, 15 (4.2%) had recurrent VTE, as compared with 14 (3.9%) of the 360 patients assigned to nadroparin. Recurrent VTE were similarly distributed throughout the study period. In the UFH group, 5 episodes occurred in the initial 2 weeks, 4 in the following month, and 6 in the remaining 6 weeks; the corresponding figures in the nadroparin group were 4, 5, and 5, respectively
Safety outcome: Major bleeding during initial treatment period occurred in 1.1% (4/360) of the patients treated with UFH, which was fatal in 1 patient. Among the 360 patients in the nadroparin group, 3 (0.8%) developed a major bleeding. During the 3 months of follow-up 12 patients in each group died (3.3%)

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Summary

Efficacy: Treatment with subcutaneous UFH with dose adjusted by aPTT by means of a weight-based algorithm is as effective and safe as fixed-dose (adjusted only for body weight) nadroparin for the initial treatment of patients with VTE, including those with PE and recurrent VTE
Safety: The incidence of major bleeding was similar with UFH and nadroparin. Overall mortality was the same in each group

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Reference

Galilei Investigators. Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism. Arch Intern Med 2004;164:1077-1083

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Corresponding author

Paolo Prandoni, MD, Department of Medical and Surgical Sciences, Second Chair of Internal Medicine, University of Padua, Via Ospedale Civile, 105, 35128 Padua, Italy, e-mail: paoloprandoni@tin.it

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