Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

Official Title: “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.

Arms, Groups and Cohorts in this Clinical Trial

• : 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

Primary Measures

• First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
  • Time Frame: 3 days
    Safety Issue?: No
• 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
    Safety Issue?: No

Secondary Measures

• interobserver reliability of modified Well's criteria
  • Time Frame: 3 days
    Safety Issue?: No
• learning curve for LC U/S by emergency physicians and residents
  • Time Frame: 365 days
    Safety Issue?: No
• difference in diagnostic time interval for patients grouped by pre-test probability
  • Time Frame: 3 days
    Safety Issue?: No
• number of return visits for formal ultrasound imaging
  • Time Frame: 3 days
    Safety Issue?: No
• number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending
  • Time Frame: 3 days
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Queen's University Other

Overall Clinical Trial Officials and Contacts

Rachel Poley, MD Principal Investigator Queen's University  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01007045

Study ID Number: EMED-123-09

ClinicalTrials.gov Identifier: NCT01007045

Health Authority: Canada: Ethics Review Committee