The ERASMUS Study: Limited vs Extended US for DVT Diagnosis
Limited Versus Extended Ultrasonography for the Diagnosis of Clinically Symptomatic Deep Vein Thrombosis of the Lower Extremities. A Randomized Study
1 other identifier
interventional
2,000
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2003
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 14, 2006
CompletedFirst Posted
Study publicly available on registry
July 17, 2006
CompletedOctober 20, 2006
July 1, 2005
July 14, 2006
October 19, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Interventions
Eligibility Criteria
You may qualify if:
- outpatients with clinically suspected deep vein thrombosis of the lower extremities
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Bernardi E, Camporese G, Buller 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. doi: 10.1001/jama.300.14.1653.
PMID: 18840838DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Enrico Bernardi, MD
Department of Emergency and Accident Medicine, University Hospital of Padua
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 14, 2006
First Posted
July 17, 2006
Study Start
January 1, 2003
Study Completion
July 1, 2005
Last Updated
October 20, 2006
Record last verified: 2005-07