Thrombus Elastography in Venous Thrombo-Embolism.

NCT04130048 | Unknown

• 1 other identifier: TEVTE ( 29BRC19. 101)
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Venous Thrombo-Embolic Disease (VTED) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. It represents the third cause of death after cardio-vascular disease and cancer, and encompass superficial, muscular and Deep Venous Thrombosis (DVT), and Pulmonary Embolisms (PE), which can be isolated or associated. Ultrasound is today the most frequently used exam to diagnose DVT. However, it's unable to provide information on thrombus age or cause. Elastography is an imaging technic which aims to analyse elastic properties of a tissue, by applying a mechanical impulse on it, and could be an interesting tool in thrombus exploration, and provide additional information.

Conditions

Venous Thromboembolism

Keywords

Elasticity Imaging Techniques; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Shear Wave Speed within the thrombus.

  Quantitative data, in meter per second.

  At VTE diagnostic (Day 0)

Interventions

Ultrasound Elastography DIAGNOSTIC_TEST

Ultrasound elastography aims to assess the stiffness of a tissue, submitting it to an ultrasound impulse.

Eligibility Criteria

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

Study Population

Any patient suffering from a proximal DVT (DVT) of at least one lower limb and admitted to the vascular medicine department of the Brest University Hospital.

You may qualify if:

• Over 18 years old.
• Suffering from a proximal DVT (DVT) of at least one lower limb.
• Thrombosis is assumed to be recent (no history of ipsilateral DVT).
• Non opposition obtained.

You may not qualify if:

• Patient suffering from an inferior vena cava thrombosis with no extension to ilio-femoral veins.
• Physical or cognitive inability to consent.
• Patient refusal.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Brest University Hospital

Brest, Finistere, 29200, France

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Luc BRESSOLLETTE

CONTACT

02-98-34-73-42; luc.bressollette@chu-brest.fr

Clement HOFFMANN

CONTACT

02.30.33.79.32; clement.hoffmann@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: October 10, 2019
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: October 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)