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CompletedNCT01007045Updated Jun 9, 2011

Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

An observational study in Deep Vein Thrombosis, sponsored by Queen's University. Completed at 2 sites in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2011-06-09.

Sponsored by Queen's University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
227
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Deep Vein Thrombosis

Keywords

  • deep vein thrombosis
  • venous thromboembolic disorders
  • diagnostic ultrasound
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 227 is close to the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

emergency patients suspected of deep vein thrombosis

Inclusion criteria

  • Age > 16 years
  • Clinically suspected lower extremity DVT

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
227 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.

    Time frame: 3 days

  2. 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

Secondary outcomes

  1. interobserver reliability of modified Well's criteria

    Time frame: 3 days

  2. learning curve for LC U/S by emergency physicians and residents

    Time frame: 365 days

  3. difference in diagnostic time interval for patients grouped by pre-test probability

    Time frame: 3 days

  4. number of return visits for formal ultrasound imaging

    Time frame: 3 days

  5. number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending

    Time frame: 3 days

07

Study locations

2 sites
  • Kingston General Hospital
    Kingston, Ontario K7L 2V7, Canada
  • Hotel Dieu Hospital
    Kingston, Ontario K7L 5G2, Canada
08

References and documents

Publications

  • Poley RA, Newbigging JL, Sivilotti ML. Estimated effect of an integrated approach to suspected deep venous thrombosis using limited-compression ultrasound. Acad Emerg Med. 2014 Sep;21(9):971-80. doi: 10.1111/acem.12459. PubMed 25269577 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01007045
Lead sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation
First posted
Nov 3, 2009
Start date
Nov 2009
Primary completion
Dec 2010
Completion
Jun 2011
Last update
Jun 9, 2011

Study contacts

Rachel Poley, MD
principal investigator · Queen's University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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