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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

Thrombosis Clinical Trial

Official title:
LITE Study, Appendix A (HOME-LITE), Amendment 6

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00203658
Study type Interventional
Source University of Calgary
Contact
Status Completed
Phase Phase 4
Start date April 1997
Completion date October 2000
View Details
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