LITE Study, Appendix A (HOME-LITE), Amendment 6
Sponsor study identifier
interventional
400
1 country
1
Study Start
April 1997
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1997
Date type not reportedThis date has not been verified as actual or estimated.
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 20, 2005
Actual (reported)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
recurrent venous thromboembolism at 12 months
death at 12 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Thrombosis Research Unit, University of Calgary
Calgary, Alberta, T2N 2T9, Canada
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.
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.
Russell D Hull, MBBS, MSc
University of Calgary
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
April 1997
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days
Contact the study team to confirm eligibility.
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.
Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
Last Updated
February 9, 2007
Record last verified: 2005-09
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Source: ClinicalTrials.gov.
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