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?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01007045

Enrollment

227

Registered

2009-11-03

Start date

2009-11-30

Completion date

2011-06-30

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Keywords

deep vein thrombosis, venous thromboembolic disorders, diagnostic ultrasound

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
difference in diagnostic time interval for patients grouped by pre-test probability	3 days
interobserver reliability of modified Well's criteria	3 days
number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending	3 days
number of return visits for formal ultrasound imaging	3 days
learning curve for LC U/S by emergency physicians and residents	365 days

Countries

Canada

Outcome results