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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Deep Vein Thrombosis

Treatments

Radiation: elastography SWIRE

Study type

Interventional

Funder types

Other

Identifiers

NCT02859532
38RC15.355

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Diagnosis of deep vein thrombosis
Experimental group
Description:
All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test.
Treatment:
Radiation: elastography SWIRE

Trial contacts and locations

1

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Central trial contact

Gilles PERNOD

Data sourced from clinicaltrials.gov

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