NCT02369263

Brief Summary

Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency Department (ED) employing the two point compression method. This study endeavors to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in the ED by EM Residents by comparing the results of that exam against the gold standard of a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

April 11, 2013

Last Update Submit

February 17, 2015

Conditions

Keywords

Deep Vein ThrombosisDVTLeg SwellingLeg PainBlood Clot

Outcome Measures

Primary Outcomes (1)

  • Outcome measures is the proportion of agreement between Resident performed two point DVT ultrasaound and the Radiologist interpertation of a formal DVT ultrasound.

    Two point Emergency Medicine Resident preformed DVT Ultrasound (5 minute procedure) results will be compared as a proportion to Radiologist interpreted ultrasonographer performed DVT Ultrasound results.

    5 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients presenting to the Emergency Departmetn suspicious of DVT

You may qualify if:

  • Age 18 or older
  • Suspect of having DVT

You may not qualify if:

  • Known DVT
  • DVT with in previous 6 months
  • DVT Ultrasound within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

MeSH Terms

Conditions

Venous ThrombosisThrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Jamie Baydoun, MD

    Emergency Medicine Physicians

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2013

First Posted

February 23, 2015

Study Start

May 1, 2013

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations