Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203580
Status:
COMPLETED
Last Update Posted:
2007-02-09
First Post:
2005-09-12
Brief Title:
Trial of the Effect of Low-Molecular-Weight Heparin LMWH Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis DVT Main LITE Study
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Randomized Trial of the Effect of Low-Molecular-Weight Heparin Versus Warfarin Sodium on the Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis Main LITE Study
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 treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin tinzaparin sodium versus the standard care use of intravenous heparin followed by oral warfarin sodium
Detailed Description:
The accepted treatment for acute deep vein thrombosis DVT is initial continuous intravenous heparin followed by long-term oral anticoagulant therapy Improvements in the methods of clinical trials and the use of accurate objective tests to detect venous thromboembolism have made it possible to perform a series of randomized trials to evaluate various treatments of venous thromboembolism
The specific objectives of the Main LITE Study are
to determine if low-molecular-weight heparin given subcutaneously once daily without laboratory monitoring is more effective than adjusted oral warfarin sodium in the reduction of mortality rate
to determine if such a low-molecular-weight heparin therapy is more cost-effective than present standard care methods
to determine the incidence of Factor V Leiden and Prothrombin 20210A mutant genetic abnormalities
The specific objectives of the Main LITE Study are
to determine if low-molecular-weight heparin given subcutaneously once daily without laboratory monitoring is more effective than adjusted oral warfarin sodium in the reduction of mortality rate
to determine if such a low-molecular-weight heparin therapy is more cost-effective than present standard care methods
to determine the incidence of Factor V Leiden and Prothrombin 20210A mutant genetic abnormalities
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