- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01007045
Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis
Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
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Kingston, Ontario, Canada, K7L 5G2
- Hotel Dieu Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Clinically "likely"
Subjects deemed clinically likely to have DVT based on modified Well's criteria
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Clinically "unlikely"
Subjects deemed clinically unlikely to have DVT based on modified Well's criteria
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
Time Frame: 3 days
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3 days
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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
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3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
interobserver reliability of modified Well's criteria
Time Frame: 3 days
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3 days
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learning curve for LC U/S by emergency physicians and residents
Time Frame: 365 days
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365 days
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difference in diagnostic time interval for patients grouped by pre-test probability
Time Frame: 3 days
|
3 days
|
number of return visits for formal ultrasound imaging
Time Frame: 3 days
|
3 days
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number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rachel Poley, MD, Queen's University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMED-123-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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