The ERASMUS Study: Limited vs Extended US for DVT Diagnosis - Full Text View

Sponsor:	University of Padova
Information provided by:	University of Padova
ClinicalTrials.gov Identifier:	NCT00353093

Purpose

Currently, patients with suspected deep vein thrombosis (DVT) of the lower extremities receive the ultrasound investigation of their deep vein system, either by limited ultrasonography (ultrasonography confined to the proximal veins, repeating the test after one week in patients with positive D-dimer) or by extended ultrasonography (ultrasonography extented to the entire deep vein system of the legs). No study has directly compared the two strategies to assess their accuracy and safety. We plan to compare the accuracy and safety of the two strategies in a prospective randomized study addressing more than 2000 consecutive outpatients presenting with the clinical suspicion of DVT.

Condition	Intervention
Deep Vein Thrombosis of the Lower Extremities	Procedure: Ultrasonography of the deep vein system of the legs

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Limited Versus Extended Ultrasonography for the Diagnosis of Clinically Symptomatic Deep Vein Thrombosis of the Lower Extremities. A Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Ultrasound

U.S. FDA Resources

Further study details as provided by University of Padova:

Primary Outcome Measures:

To assess(1) the prevalence and location of venous thrombosis
as shown by the initial diagnostic workup; (2) the rate of
symptomatic venous thromboembolic events (including proximal
vein thrombosis, isolated thrombosis of the tibial or peroneal
veins in either leg, and pulmonary embolism) during three months
of follow up in patients with an initially normal diagnostic workup.

Estimated Enrollment:	2000
Study Start Date:	January 2003
Estimated Study Completion Date:	July 2005

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

outpatients with clinically suspected deep vein thrombosis of the lower extremities

Exclusion Criteria:

history of previous venous thromboembolism
clinical suspicion of pulmonary embolism
life expectancy shorter than 3 months
therapeutic doses of unfractionated heparin, low molecular weight heparin or oral anticoagulants for more than 48 hours
another indication for anticoagulant treatment
pregnancy
age less than 18 years
inaccessibility to follow-up
refused participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353093

Sponsors and Collaborators

University of Padova

Investigators

Principal Investigator:

Enrico Bernardi, MD

Department of Emergency and Accident Medicine, University Hospital of Padua

More Information

No publications provided by University of Padova

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bernardi E, Camporese G, Büller HR, Siragusa S, Imberti D, Berchio A, Ghirarduzzi A, Verlato F, Anastasio R, Prati C, Piccioli A, Pesavento R, Bova C, Maltempi P, Zanatta N, Cogo A, Cappelli R, Bucherini E, Cuppini S, Noventa F, Prandoni P; Erasmus Study Group. Serial 2-point ultrasonography plus D-dimer vs whole-leg color-coded Doppler ultrasonography for diagnosing suspected symptomatic deep vein thrombosis: a randomized controlled trial. JAMA. 2008 Oct 8;300(14):1653-9.

ClinicalTrials.gov Identifier:	NCT00353093 History of Changes
Other Study ID Numbers:	07/01
Study First Received:	July 14, 2006
Last Updated:	October 19, 2006
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Padova:

deep vein thrombosis,D-dimer,ultrasonography

Additional relevant MeSH terms:

Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012