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

NCT00203658 | Completed Phase 4

• 1 other identifier: 2736-2
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis; Thromboembolism; Venous Thrombosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• recurrent venous thromboembolism at 12 months

• death at 12 months

Interventions

Tinzaparin sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having a first or recurrent episode of acute proximal vein thrombosis who are eligible for outpatient or home care during the initial therapy.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• LEO Pharma: collaborator
• Dupont Applied Biosciences: collaborator

Study Sites (1)

Thrombosis Research Unit, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related 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. doi: 10.1056/NEJM199603143341102.

  PMID: 8594426 BACKGROUND

• 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. doi: 10.1056/NEJM199603143341101.

  PMID: 8594425 BACKGROUND

• 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.

  PMID: 1929681 BACKGROUND

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

  PMID: 7168798 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Thromboembolism; Venous Thrombosis

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Russell D Hull, MBBS, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 1997
• Study Completion: October 1, 2000
• Last Updated: February 9, 2007

Record last verified: 2005-09

Locations

CA (1)