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Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

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ClinicalTrials.gov Identifier: NCT01007045
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : June 9, 2011
Information provided by:

Study Description
Brief Summary:

Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound.

The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.

Condition or disease
Deep Vein Thrombosis

Study Design

Study Type : Observational
Actual Enrollment : 227 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?
Study Start Date : November 2009
Primary Completion Date : December 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Clinically "likely"
Subjects deemed clinically likely to have DVT based on modified Well's criteria
Clinically "unlikely"
Subjects deemed clinically unlikely to have DVT based on modified Well's criteria

Outcome Measures

Primary Outcome Measures :
  1. First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients. [ Time Frame: 3 days ]
  2. Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. interobserver reliability of modified Well's criteria [ Time Frame: 3 days ]
  2. learning curve for LC U/S by emergency physicians and residents [ Time Frame: 365 days ]
  3. difference in diagnostic time interval for patients grouped by pre-test probability [ Time Frame: 3 days ]
  4. number of return visits for formal ultrasound imaging [ Time Frame: 3 days ]
  5. number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending [ Time Frame: 3 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
emergency patients suspected of deep vein thrombosis

Inclusion Criteria:

  • Age > 16 years
  • Clinically suspected lower extremity DVT

Exclusion Criteria:

  • Known chronic DVT
  • Acute DVT confirmed by prior formal imaging
  • Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.)
  • Anticoagulation >48 hours prior to imaging (formal or LCU)
Contacts and Locations

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): NCT01007045

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Principal Investigator: Rachel Poley, MD Queen's University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Rachel Poley, Queen's University
ClinicalTrials.gov Identifier: NCT01007045     History of Changes
Other Study ID Numbers: EMED-123-09
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by Queen's University:
deep vein thrombosis
venous thromboembolic disorders
diagnostic ultrasound

Additional relevant MeSH terms:
Venous Thrombosis
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases