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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Dupont Applied Biosciences
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00203658
First received: September 12, 2005
Last updated: February 8, 2007
Last verified: September 2005
  Purpose

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 Intervention Phase
Thrombosis
Thromboembolism
Venous Thrombosis
Drug: Tinzaparin sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: LITE Study, Appendix A (HOME-LITE), Amendment 6

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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:
  • recurrent venous thromboembolism at 12 months
  • death at 12 months

Estimated Enrollment: 400
Study Start Date: April 1997
Estimated Study Completion Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203658

Locations
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
Investigators
Principal Investigator: Russell D Hull, MBBS, MSc University of Calgary
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00203658     History of Changes
Other Study ID Numbers: 2736-2
Study First Received: September 12, 2005
Last Updated: February 8, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Thromboembolism
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014