Thrombus Elastography in Venous Thrombo-Embolism. (TEVTE)

Assessment of Thrombus Stiffness Using Ultrasound Elastography in Venous Thrombo-embolism.

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.

Study Overview

• Status: Unknown
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Diagnostic test: Ultrasound Elastography

Detailed Description

Proximal deep venous thrombosis of a lower limb was defined as any venous thrombosis involving the ilio-femoral and/or femoro-popliteal axes, with or without cava thrombosis or distal DVT.

A DVT was assumed provoked, as recommended by AFSSAPS (2009) and ACCP (2012), when there was a major transient risk factor (surgery, prolonged immobilization ≥3 days, lower limb fracture) in the last three months, or a persistent risk factor (Antiphospholipid syndrome, active cancer). In case of absence of at least one of these factors, DVT was considered unprovoked.

A DVT was supposed recent when there was no known DVT in the patient medical history.

The association with a Pulmonary Embolism was assessed by the presence of PE diagnosis in the medical report. It had to be diagnosed following the ESC guidelines, with a thoracic CT scan and/or a V/Q lung scan.

In this study, we analysed the shear wave's velocity (expressed in m/s).

Acquisitions were obtained during the venous ultrasound realised for the diagnosis of DVT. All measures were made on the same ultrasonic device, with the ShearWave module.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• France
  • Finistere
    • Brest, Finistere, France, 29200
      • Recruiting
      • Brest University Hospital
      • Contact: Luc Bressollette; Email: luc.bressollette@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shear Wave Speed within the thrombus.	Quantitative data, in meter per second.	At VTE diagnostic (Day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Anticipated): December 14, 2019
• Study Completion (Anticipated): December 14, 2019

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Venous Thromboembolism; Elasticity Imaging Techniques
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: TEVTE ( 29BRC19. 101)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning one year and ending five years following the publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No