Clinical trial NCT02262494: Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography
Official title: Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deep Vein Thrombosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnosis of deep vein thrombosis by portable ultrasound: yes/no
timeFrame: Day 0
measure: Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no
timeFrame: Day 0
Secondary outcomes:
measure: Diagnosis of deep vein thrombosis by classic ultrasound: yes/no
timeFrame: day 0
measure: Wells score
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Xavier Bobbia, MD
role: PRINCIPAL_INVESTIGATOR
References: