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

Primary Purpose

Deep Vein Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
elastography SWIRE
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring blood coagulation, Endogenous Thrombin Potential, rotational thromboelastometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital GrenobleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnosis of deep vein thrombosis

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated
Thrombus properties if provoked versus unprovoked thrombosis
Correlation of the thrombus in vivo properties to the thrombin generation capacity and viscoelastic properties tested ex vivo by rotational thromboelastometry

Full Information

First Posted
July 28, 2016
Last Updated
January 4, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02859532
Brief Title
Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
Acronym
ClotStruct
Official Title
Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
blood coagulation, Endogenous Thrombin Potential, rotational thromboelastometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnosis of deep vein thrombosis
Arm Type
Experimental
Arm Description
All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test.
Intervention Type
Radiation
Intervention Name(s)
elastography SWIRE
Other Intervention Name(s)
Supersonic Imagine
Primary Outcome Measure Information:
Title
Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography
Time Frame
Day 0, Day 7, Day 30
Secondary Outcome Measure Information:
Title
Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated
Time Frame
Day 0, Day 7, Day 30
Title
Thrombus properties if provoked versus unprovoked thrombosis
Time Frame
Day 0, Day 7, Day 30
Title
Correlation of the thrombus in vivo properties to the thrombin generation capacity and viscoelastic properties tested ex vivo by rotational thromboelastometry
Time Frame
Day 0, Day 7, Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles PERNOD
Phone
00 334 767 657 17
Email
GPernod@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles PERNOD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Pernod

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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