NCT00203658

Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis (DVT) Using Low-Molecular-Weight Heparin (LMWH) Versus LMWH Followed by Warfarin

LITE Study, Appendix A (HOME-LITE), Amendment 6

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.

Detailed description

Two studies demonstrated that out-of-hospital low-molecular-weight heparin given by twice daily subcutaneous injection without laboratory monitoring was as effective and as safe as continuous intravenous heparin given in-hospital. Innohep (tinzaparin) has been shown to be safe and effective for both the initial and long-term treatment of DVT. The Home LITE study compares long-term Innohep treatment to treatment with a combination of initial low-molecular-weight heparin followed by standard long-term warfarin therapy.

Conditions

• Thrombosis
• Thromboembolism
• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Tinzaparin sodium

Timeline

• Start date: 1997-04-01
• Completion: 2000-10-01
• First posted: 2005-09-20
• Last updated: 2007-02-09

Locations

1 site across 1 country: Canada