Clinical trial NCT02859532: Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
Official title: Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: blood coagulation
Endogenous Thrombin Potential
rotational thromboelastometry
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography
timeFrame: Day 0, Day 7, Day 30
Secondary outcomes:
measure: Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated
timeFrame: Day 0, Day 7, Day 30
measure: Thrombus properties if provoked versus unprovoked thrombosis
timeFrame: Day 0, Day 7, Day 30
measure: Correlation of the thrombus in vivo properties to the thrombin generation capacity and viscoelastic properties tested ex vivo by rotational thromboelastometry
timeFrame: Day 0, Day 7, Day 30
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles PERNOD
role: PRINCIPAL_INVESTIGATOR
References: