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Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography (EchoComp TVP)

Primary Purpose

Deep Vein Thrombosis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
portable venous compression ultrasonography
venous compress ultrasonography
Doppler ultrasound of the lower limbs
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Suspected first episode of DVT

Arm Description

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

Outcomes

Primary Outcome Measures

Diagnosis of deep vein thrombosis by portable ultrasound: yes/no
Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no

Secondary Outcome Measures

Diagnosis of deep vein thrombosis by classic ultrasound: yes/no
Wells score
score ranging from 0 to 6

Full Information

First Posted
October 2, 2014
Last Updated
January 2, 2018
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02262494
Brief Title
Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography
Acronym
EchoComp TVP
Official Title
Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
No recruitment
Study Start Date
April 10, 2015 (Actual)
Primary Completion Date
October 19, 2016 (Actual)
Study Completion Date
October 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suspected first episode of DVT
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
portable venous compression ultrasonography
Intervention Description
venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
Intervention Type
Procedure
Intervention Name(s)
venous compress ultrasonography
Intervention Description
venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
Intervention Type
Procedure
Intervention Name(s)
Doppler ultrasound of the lower limbs
Intervention Description
Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)
Primary Outcome Measure Information:
Title
Diagnosis of deep vein thrombosis by portable ultrasound: yes/no
Time Frame
Day 0
Title
Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Diagnosis of deep vein thrombosis by classic ultrasound: yes/no
Time Frame
day 0
Title
Wells score
Description
score ranging from 0 to 6
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Bobbia, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography

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