Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

June 8, 2011 updated by: Queen's University

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

emergency patients suspected of deep vein thrombosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
Time Frame: 3 days
3 days
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
3 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rachel Poley, MD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 2, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Vein Thrombosis

3
Subscribe