Clinical trial NCT00689520: Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thromboembolism
Keywords: Venous thromboembolism
low molecular weight heparin
Vitamin K antagonist
Longterm
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2008-06-03
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Incidence of symptomatic recurrent venous thromboembolism
timeFrame: 12 months
Secondary outcomes:
measure: Occurrence of major bleeding
timeFrame: 6 month treatment interval
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Vascular surgery service. Hospital Creu Roja de l'Hospitalet
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Department of Vascular Surgery. Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Antoni Romera, MD
role: STUDY_CHAIR
affiliation: Hospital Universitari de Bellvitge
name: Antoni Romera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Creu Roja de l'Hospitalet
name: Oriol Lapiedra, MD
role: PRINCIPAL_INVESTIGATOR
References: