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

Deep Vein Thrombosis Clinical Trial

— EchoComp TVP  

Official title:

Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02262494
• Other study ID #: LOCAL/2013/XB-01
• Secondary ID: 2014-A00510-47
• Status: Terminated
• Phase: N/A
• First received: October 2, 2014
• Last updated: January 2, 2018
• Start date: April 10, 2015
• Est. completion date: October 19, 2016

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: October 19, 2016
• Est. primary completion date: October 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Emergencies
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• portable venous compression ultrasonography
venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
• venous compress ultrasonography
venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
• Doppler ultrasound of the lower limbs
Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of deep vein thrombosis by portable ultrasound: yes/no		Day 0
Primary	Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no		Day 0
Secondary	Diagnosis of deep vein thrombosis by classic ultrasound: yes/no		day 0
Secondary	Wells score	score ranging from 0 to 6	Day 0