Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203658
Status:
COMPLETED
Last Update Posted:
2007-02-09
First Post:
2005-09-12
Brief Title:
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
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
LITE Study Appendix A HOME-LITE Amendment 6
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None