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

Phase 4

Completed

• Conditions: Thrombosis; Thromboembolism; Venous Thrombosis

• Registration Number: NCT00203658
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 1997-04
• Study Completion: 2000-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Submitted: 2007-02-08
• Last Update Posted: 2007-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
recurrent venous thromboembolism at 12 months
death at 12 months

Trial Locations

Locations (1)

Thrombosis Research Unit, University of Calgary; 🇨🇦 Calgary, Alberta, Canada