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The ERASMUS Study: Limited vs Extended US for DVT Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00353093
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : October 20, 2006
Sponsor:
Information provided by:
University of Padova

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis of the Lower Extremities Procedure: Ultrasonography of the deep vein system of the legs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2003
Study Completion Date : July 2005

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353093


Sponsors and Collaborators
University of Padova
Investigators
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Principal Investigator: Enrico Bernardi, MD Department of Emergency and Accident Medicine, University Hospital of Padua
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00353093    
Other Study ID Numbers: 07/01
First Posted: July 17, 2006    Key Record Dates
Last Update Posted: October 20, 2006
Last Verified: July 2005
Keywords provided by University of Padova:
deep vein thrombosis,D-dimer,ultrasonography
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases