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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00203658
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 9, 2007
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Dupont Applied Biosciences
Information provided by:
University of Calgary

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.

Condition or disease Intervention/treatment Phase
Thrombosis Thromboembolism Venous Thrombosis Drug: Tinzaparin sodium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LITE Study, Appendix A (HOME-LITE), Amendment 6
Study Start Date : April 1997
Study Completion Date : October 2000

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
  2. death during initial treatment or during the 12 week follow-up period
  3. safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval

Secondary Outcome Measures :
  1. recurrent venous thromboembolism at 12 months
  2. death at 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00203658

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Canada, Alberta
Thrombosis Research Unit, University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Dupont Applied Biosciences
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Principal Investigator: Russell D Hull, MBBS, MSc University of Calgary

Layout table for additonal information Identifier: NCT00203658    
Other Study ID Numbers: 2736-2
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 9, 2007
Last Verified: September 2005
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action