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?
1 other identifier
observational
227
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
2 active sites
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
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 9, 2011
June 1, 2011
1.1 years
November 2, 2009
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
3 days
Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients.
3 days
Secondary Outcomes (5)
interobserver reliability of modified Well's criteria
3 days
learning curve for LC U/S by emergency physicians and residents
365 days
difference in diagnostic time interval for patients grouped by pre-test probability
3 days
number of return visits for formal ultrasound imaging
3 days
number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending
3 days
Study Arms (2)
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
Eligibility Criteria
emergency patients suspected of deep vein thrombosis
You may qualify if:
- Age \> 16 years
- Clinically suspected lower extremity DVT
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
Related Publications (1)
Poley RA, Newbigging JL, Sivilotti ML. Estimated effect of an integrated approach to suspected deep venous thrombosis using limited-compression ultrasound. Acad Emerg Med. 2014 Sep;21(9):971-80. doi: 10.1111/acem.12459.
PMID: 25269577DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Poley, MD
Queen's University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 3, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
June 9, 2011
Record last verified: 2011-06