A Phase 4 interventional study of Tinzaparin sodium in Thrombosis, Thromboembolism and Venous Thrombosis, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-02-09.
Sponsored by University of Calgary · Phase 4, Interventional, and Treatment
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.
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 400 is above the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
death during initial treatment or during the 12 week follow-up period
safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval
recurrent venous thromboembolism at 12 months
death at 12 months
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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University of Calgary