Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

Deep Vein Thrombosis Clinical Trial

Official title:

Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007045
• Other study ID #: EMED-123-09
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: June 8, 2011
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.		3 days	No
Primary	Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients.		3 days	No
Secondary	interobserver reliability of modified Well's criteria		3 days	No
Secondary	learning curve for LC U/S by emergency physicians and residents		365 days	No
Secondary	difference in diagnostic time interval for patients grouped by pre-test probability		3 days	No
Secondary	number of return visits for formal ultrasound imaging		3 days	No
Secondary	number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending		3 days	No