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

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT00203658

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), LEO Pharma (Industry), Dupont Applied Biosciences (Industry)

400

Enrollment

Location

Duration (Months)

9.5

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 1997

Study Completion Date :

Oct 1, 2000

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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