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

• Status: Completed
• Trial end date: 2000-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR); Dupont Applied Biosciences; LEO Pharma
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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