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

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: Deep Vein Thrombosis
• Intervention / Treatment: Procedure: portable venous compression ultrasonography; Procedure: venous compress ultrasonography; Procedure: Doppler ultrasound of the lower limbs

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

Study Locations

• France
  • Nîmes Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

Procedure: portable venous compression ultrasonography; venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician); Procedure: venous compress ultrasonography; venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist); Procedure: Doppler ultrasound of the lower limbs; 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	Day 0
Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of deep vein thrombosis by classic ultrasound: yes/no		day 0
Wells score	score ranging from 0 to 6	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

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: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: LOCAL/2013/XB-01; 2014-A00510-47 (Other Identifier: RCB number)