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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203658
• Other study ID #: 2736-2
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 8, 2007
• Start date: April 1997
• Est. completion date: October 2000

Study information

• Verified date: September 2005
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Tinzaparin sodium

Locations

Country	Name	City	State
Canada	Thrombosis Research Unit, University of Calgary	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR), Dupont Applied Biosciences, LEO Pharma

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. Erratum in: N Engl J Med 1997 Oct 23;337(17):1251. — View Citation

Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
Primary	death during initial treatment or during the 12 week follow-up period
Primary	safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval
Secondary	recurrent venous thromboembolism at 12 months
Secondary	death at 12 months