Abbreviated hospitalization for deep venous thrombosis with the use of ardeparin.

Abstract

BACKGROUND:

Ardeparin sodium has recently received approval by the Food and Drug Administration for prophylaxis against venous thromboembolism in patients undergoing elective total knee replacement. However, this low-molecular-weight heparin has not been previously evaluated in a randomized controlled trial for treatment of established acute deep venous thrombosis.

METHODS:

The study included patients with ultrasound-documented acute symptomatic deep venous thrombosis of the legs. They had to be deemed appropriate for discharge home to receive subcutaneous low-molecular-weight heparin. Patients were randomized to receive ardeparin with a 2-day hospitalization or unfractionated heparin sodium with a 5-day hospitalization. Both groups received warfarin sodium. Follow-up ultrasound examinations were undertaken at 6 weeks.

RESULTS:

Of the 80 patients enrolled, 75 had follow-up ultrasonography. Evaluation of baseline vs 6-week venous scans demonstrated that, overall, 31 of the 39 ardeparin-treated patients improved, compared with 21 of the 36 patients assigned to receive unfractionated heparin (P=.05). The 95% confidence interval for the difference in improvement was 0.6% to 42% in favor of ardeparin. Median charges for ardeparin and unfractionated heparin were $2815 and $6500, respectively (P<.001). There were no differences in bleeding or patient satisfaction between the 2 groups.

CONCLUSIONS:

The results of this small preliminary trial suggest that ardeparin can be administered effectively and safely to selected patients with acute deep venous thrombosis and that, with proper nursing and home services, it can help decrease the duration of hospitalization.

• Authors: S Z Goldhaber, R B Morrison, L L Diran, M A Creager, T H Lee Jr
• Journal: Archives of internal medicine (Arch Intern Med) Vol. 158 Issue 21 Pg. 2325-8 (Nov 23 1998) ISSN: 0003-9926 [Print] United States
• PMID: 9827783 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Heparin, Low-Molecular-Weight
• Warfarin
• Heparin
• ardeparin

Topics

• Anticoagulants (administration & dosage, therapeutic use)
• Confidence Intervals
• Drug Approval
• Female
• Follow-Up Studies
• Hemorrhage (chemically induced)
• Heparin (administration & dosage, therapeutic use)
• Heparin, Low-Molecular-Weight (administration & dosage, therapeutic use)
• Hospitalization
• Humans
• Infusions, Intravenous
• Injections, Subcutaneous
• Leg (blood supply, diagnostic imaging)
• Length of Stay
• Male
• Middle Aged
• Patient Satisfaction
• Ultrasonography
• United States
• United States Food and Drug Administration
• Venous Thrombosis (diagnostic imaging, drug therapy)
• Warfarin (administration & dosage, therapeutic use)