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

Information source: Hospital Universitari de Bellvitge
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism

Intervention: tinzaparin (Drug); acenocoumarol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Universitari de Bellvitge

Official(s) and/or principal investigator(s):
Antoni Romera, MD, Study Chair, Affiliation: Hospital Universitari de Bellvitge
Antoni Romera, MD, Principal Investigator, Affiliation: Hospital Universitari de Bellvitge
Oriol Lapiedra, MD, Principal Investigator, Affiliation: Hospital Creu Roja de l'Hospitalet

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of symptomatic recurrent venous thromboembolism

Secondary outcome: Occurrence of major bleeding

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Department of Vascular Surgery. Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona 08907, Spain

Vascular surgery service. Hospital Creu Roja de l'Hospitalet, L'Hospitalet de Llobregat, Barcelona 08906, Spain

Additional Information

Starting date: January 2002
Last updated: June 2, 2008

Page last updated: August 23, 2015

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