Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)

NCT ID: NCT02859532

Last Updated: 2019-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-02-28

Brief Summary

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Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus within the venous system, mainly the lower limbs. The clot structure directly influences both its location, but also its progressive profile expansion material or regression and embolic migration.

Few data are available regarding the evolution of structural properties of thrombus after an acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how the thrombus responds to forces which it is subjected.

Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to study its evolutionary properties.

Detailed Description

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The main objective of the study is to characterize the in vivo properties of elastographic thrombus in patients with proximal deep vein thrombosis (DVT), for quantitative elastography performed at D0, D7, D30.

The ability to analyze the structural properties of the thrombus should allow us to then correlate these properties to the evolving nature of the thrombus (embolic migration or not, recanalization or not), and the effect of different treatment on the evolution of the thrombus

Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diagnosis of deep vein thrombosis

All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test.

Group Type EXPERIMENTAL

elastography SWIRE

Intervention Type RADIATION

Interventions

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elastography SWIRE

Intervention Type RADIATION

Other Intervention Names

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Supersonic Imagine

Eligibility Criteria

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Inclusion Criteria

* Patient with proximal DVT, provoked or not, the symptomatology is less than 3d, with or without pulmonary embolism treated with heparin or oral anticoagulant
* Signed informed consent
* Patient affiliated to a social security scheme,

Exclusion Criteria

* pregnant or lactating
* Life expectancy \<1 month
* Patient with distal DVT or asymptomatic DVT accidental discovery
* Patient who underwent venous unclogging in acute phase
* exclusion period in another study,
* under administrative or judicial oversight, under guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles PERNOD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilles PERNOD

Role: CONTACT

00 334 767 657 17

Facility Contacts

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Gilles Pernod

Role: primary

Other Identifiers

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38RC15.355

Identifier Type: -

Identifier Source: org_study_id

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