Venous Thromboembolism Clinical Trial
Official title:
Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis
Verified date | May 2008 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
Status | Completed |
Enrollment | 241 |
Est. completion date | January 2005 |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs. - either sex and over 18 years of age - referred to the Vascular Surgery Department of the hospital - onset of symptoms less than 2 weeks - documented by compression ultrasonography, Exclusion Criteria: - received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease - pulmonary embolism requiring thrombolytic therapy - Need of surgical thrombectomy or vena cava interruption - receiving oral anticoagulant treatment or antiplatelet agents for other conditions - contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs) - platelet count lower than 100x103 /µl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia - severe renal failure necessitating dialysis - pregnancy - lumbar puncture within the previous 24 hours |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Department of Vascular Surgery. Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona |
Spain | Vascular surgery service. Hospital Creu Roja de l'Hospitalet | L'Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge | LEO Pharma |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of symptomatic recurrent venous thromboembolism | 12 months | No | |
Secondary | Occurrence of major bleeding | 6 month treatment interval | Yes |
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