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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thrombosis, Thromboembolism, Venous Thrombosis

Intervention / Treatment
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* Drug: Tinzaparin sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having a first or recurrent episode of acute proximal vein thrombosis who are eligible for outpatient or home care during the initial therapy. Exclusion Criteria: Any condition which, in the opinion of the investigator, precludes entire out-of-hospital treatment Presence of familial bleeding diathesis or the presence of active bleeding contraindicating anticoagulant therapy Receiving therapeutic heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis Receiving long-term warfarin treatment Females who are pregnant Known allergy to heparin, warfarin sodium, or bisulfites History of heparin-associated thrombocytopenia Severe malignant hypertension Hepatic encephalopathy Severe renal failure Inability to attend follow-up due to geographic inaccessibility Inability or refusal to give signed informed consent Mothers who are breast-feeding and who are unable to refuse to discontinue breast-feeding during study treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tinzaparin sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent venous thromboembolism at 12 months |  |  | 
| death at 12 months |  |  |