Overview

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

Status:
Completed
Trial end date:
2005-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborator:
LEO Pharma
Treatments:
Acenocoumarol
Anticoagulants
Calcium heparin
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Vitamin K
Vitamins
Criteria
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