Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

Completed

• Conditions: Deep Vein Thrombosis

• Registration Number: NCT01007045
• Lead Sponsor: Queen's University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2010-12
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada