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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02859532
Acronym
ClotStruct
Enrollment
30
Registered
2016-08-09
Start date
2017-01-31
Completion date
2019-02-28
Last updated
2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Keywords

blood coagulation, Endogenous Thrombin Potential, rotational thromboelastometry

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

Interventions

RADIATIONelastography SWIRE

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastographyDay 0, Day 7, Day 30

Secondary

MeasureTime frame
Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associatedDay 0, Day 7, Day 30
Thrombus properties if provoked versus unprovoked thrombosisDay 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 thromboelastometryDay 0, Day 7, Day 30

Countries

France

Contacts

Primary ContactGilles PERNOD
GPernod@chu-grenoble.fr00 334 767 657 17

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026