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

NCT02262494 | Terminated

• 2 other identifiers: LOCAL/2013/XB-012014-A00510-47
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Diagnosis of deep vein thrombosis by classic ultrasound: yes/no

  day 0

• Wells score

  Day 0

Study Arms (1)

Suspected first episode of DVT

OTHER

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; Procedure: venous compress ultrasonography; Procedure: Doppler ultrasound of the lower limbs

Interventions

portable venous compression ultrasonography PROCEDURE

venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)

Suspected first episode of DVT

venous compress ultrasonography PROCEDURE

venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)

Suspected first episode of DVT

Doppler ultrasound of the lower limbs PROCEDURE

Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)

Suspected first episode of DVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xavier Bobbia, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 13, 2014
• Study Start: April 10, 2015
• Primary Completion: October 19, 2016
• Study Completion: October 19, 2016
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

FR (1)