Thrombus Elastography in Venous Thrombo-Embolism.

Venous Thromboembolism Clinical Trial

— TEVTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04130048
• Other study ID #: TEVTE ( 29BRC19. 101)
• Status: Recruiting
• Start date: October 10, 2019
• Est. completion date: December 14, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Brest
• Contact: Luc BRESSOLLETTE
• Phone: 02-98-34-73-42
• Email: luc.bressollette[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 14, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Diagnostic Test:
• Ultrasound Elastography
Ultrasound elastography aims to assess the stiffness of a tissue, submitting it to an ultrasound impulse.

Locations

Country	Name	City	State
France	Brest University Hospital	Brest	Finistere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shear Wave Speed within the thrombus.	Quantitative data, in meter per second.	At VTE diagnostic (Day 0)