Thrombosis, Thromboembolism, Venous Thrombosis
Conditions
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.
Interventions
Sponsors
Canadian Institutes of Health Research (CIHR)
LEO Pharma
Dupont Applied Biosciences
University of Calgary
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| recurrent venous thromboembolism at 12 months | — |
| death at 12 months | — |
Countries
Canada
Outcome results
None listed