Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis

Catalan Institute of Health

Status and phase

Completed

Phase 4

Conditions

Venous Thromboembolism

Treatments

Drug: tinzaparin

Drug: acenocoumarol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00689520

CV1/01

Details and patient eligibility

About

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.

Full description

The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.

Enrollment

241 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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