Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography (EchoComp TVP)
January 2, 2018 updated by: Centre Hospitalier Universitaire de Nīmes
Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study
The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT.
The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.
Study Overview
Status
Terminated
Conditions
Detailed Description
The secondary objectives of this study are:
- to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (V-Scan®) with that of emergency compression ultrasonography performed with a classic device
- to compare the diagnostic performance of emergency compression ultrasonography between patients suspected of having DVT arriving through the emergency department versus similar patients sent in by their generalist
- to compare the diagnostic performance of emergency compression ultrasonography among patients with suspected DVT according to pre clinical probability testing based on the Wells score (low, medium or high probability).
Currently, the use of ultra-portable ultrasound in this indication is not part of routine care, and this study is therefore considered interventional in nature.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
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
-
-
-
Nîmes Cedex 9, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient must have given informed consent and signed consent
- The patient must be a member or beneficiary of a health insurance plan
- Patient consulting in the vascular exploration and medicine department for suspected first episode of deep vein thrombosis
- Ambulatory patient: defined as any outpatient coming in for a consult directly from their place of residence or via the emergency department
- Patient does not have a history of venous thromboembolism
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is an adult under any kind of guardianship
- The patient refuses to sign the consent
- It is not possible to correctly inform the patient
- Patient has a history of venous thromboembolism
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Suspected first episode of DVT
The study population consists of patients presenting with suspected first episode of DVT at the Nîmes University Hospital. Intervention: portable venous compression ultrasonography Intervention: venous compress ultrasonography Intervention: Doppler ultrasound of the lower limbs |
venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diagnosis of deep vein thrombosis by portable ultrasound: yes/no
Time Frame: Day 0
|
Day 0
|
|
Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no
Time Frame: Day 0
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis of deep vein thrombosis by classic ultrasound: yes/no
Time Frame: day 0
|
day 0
|
|
|
Wells score
Time Frame: Day 0
|
score ranging from 0 to 6
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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 (Actual)
April 10, 2015
Primary Completion (Actual)
October 19, 2016
Study Completion (Actual)
October 19, 2016
Study Registration Dates
First Submitted
October 2, 2014
First Submitted That Met QC Criteria
October 8, 2014
First Posted (Estimate)
October 13, 2014
Study Record Updates
Last Update Posted (Actual)
January 3, 2018
Last Update Submitted That Met QC Criteria
January 2, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2013/XB-01
- 2014-A00510-47 (Other Identifier: RCB number)
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.