Back to resultsAssessment 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
Primary Purpose
Thrombosis, Thromboembolism, Venous Thrombosis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Tinzaparin sodium
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosis
Eligibility 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
Sites / Locations
- Thrombosis Research Unit, University of Calgary
Outcomes
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
Full Information
NCT ID
NCT00203658
First Posted
September 12, 2005
Last Updated
February 8, 2007
Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), LEO Pharma, Dupont Applied Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT00203658
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
Official Title
LITE Study, Appendix A (HOME-LITE), Amendment 6
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), LEO Pharma, Dupont Applied Biosciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Thromboembolism, Venous Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tinzaparin sodium
Primary Outcome Measure Information:
Title
objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
Title
death during initial treatment or during the 12 week follow-up period
Title
safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval
Secondary Outcome Measure Information:
Title
recurrent venous thromboembolism at 12 months
Title
death at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell D Hull, MBBS, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thrombosis Research Unit, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
8594426
Citation
Koopman MM, Prandoni P, Piovella F, Ockelford PA, Brandjes DP, van der Meer J, Gallus AS, Simonneau G, Chesterman CH, Prins MH. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. The Tasman Study Group. N Engl J Med. 1996 Mar 14;334(11):682-7. doi: 10.1056/NEJM199603143341102. Erratum In: N Engl J Med 1997 Oct 23;337(17):1251.
Results Reference
background
PubMed Identifier
8594425
Citation
Levine M, Gent M, Hirsh J, Leclerc J, Anderson D, Weitz J, Ginsberg J, Turpie AG, Demers C, Kovacs M. A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med. 1996 Mar 14;334(11):677-81. doi: 10.1056/NEJM199603143341101.
Results Reference
background
PubMed Identifier
1929681
Citation
Lancaster TR, Singer DE, Sheehan MA, Oertel LB, Maraventano SW, Hughes RA, Kistler JP. The impact of long-term warfarin therapy on quality of life. Evidence from a randomized trial. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. Arch Intern Med. 1991 Oct;151(10):1944-9. Erratum In: Arch Intern Med 1992 Apr;152(4):825.
Results Reference
background
PubMed Identifier
7168798
Citation
Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
Results Reference
background
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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
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