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

NCT02859532 | Unknown

• 1 other identifier: 38RC15.355
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Vein Thrombosis

Keywords

blood coagulation; Endogenous Thrombin Potential; rotational thromboelastometry

Outcome Measures

Primary Outcomes (1)

• Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography

  Day 0, Day 7, Day 30

Secondary Outcomes (3)

• Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated

  Day 0, Day 7, Day 30

• Thrombus properties if provoked versus unprovoked thrombosis

  Day 0, Day 7, Day 30

• Correlation of the thrombus in vivo properties to the thrombin generation capacity and viscoelastic properties tested ex vivo by rotational thromboelastometry

  Day 0, Day 7, Day 30

Study Arms (1)

Diagnosis of deep vein thrombosis

EXPERIMENTAL

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

Radiation: elastography SWIRE

Interventions

elastography SWIRE RADIATION

Also known as: Supersonic Imagine

Diagnosis of deep vein thrombosis

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• pregnant or lactating
• Life expectancy \<1 month
• Patient with distal DVT or asymptomatic DVT accidental discovery
• Patient who underwent venous unclogging in acute phase
• under administrative or judicial oversight, under guardianship

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, France

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gilles PERNOD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles PERNOD

CONTACT

00 334 767 657 17; GPernod@chu-grenoble.fr

Study Design

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

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 9, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)