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

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

MedlinePlus related topics:

Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study

Official Title:	Limited Versus Extended Ultrasonography for the Diagnosis of Clinically Symptomatic Deep Vein Thrombosis of the Lower Extremities. A Randomized Study

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

Publications indexed to this study:

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.

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

Keywords provided by University of Padova:

deep vein thrombosis,D-dimer,ultrasonography

Study placed in the following topic categories:

Embolism and Thrombosis

Embolism

Vascular Diseases

Fibrin fragment D

Venous Thrombosis

Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008

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