Deep Vein ThrombosisClotStructNCT02859532
Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
A study testing elastography SWIRE in people with Deep Vein Thrombosis, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- elastography SWIRE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble
Gilles Pernod
About this study
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.
Read the 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
- Conditions
- Deep Vein Thrombosis
- Being tested
- elastography SWIRE
- Keywords
- blood coagulation, Endogenous Thrombin Potential, rotational thromboelastometry
- Medical subject headings
- Venous Thrombosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastography SWIRERadiation
Also called Supersonic Imagine
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of deep vein thrombosis | Experimental | All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test. Receives: Radiation: elastography SWIRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography
Measured: Day 0, Day 7, Day 30
Secondary outcomes (3)
Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated
Measured: Day 0, Day 7, Day 30
Thrombus properties if provoked versus unprovoked thrombosis
Measured: 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
Measured: Day 0, Day 7, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles PERNOD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859532
- Sponsor's protocol ID
- 38RC15.355
- Acronym
- ClotStruct
- Status last verified
- Jan 2019
- First submitted
- 28 Jul 2016
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
- ClinicalTrials.gov ID
- NCT02859532
- Acronym / sponsor ID
- ClotStruct / 38RC15.355
- Conditions
- Deep Vein Thrombosis
- Keywords
- blood coagulation, Endogenous Thrombin Potential, rotational thromboelastometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of deep vein thrombosis | Experimental | Radiation: elastography SWIREAll subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastography SWIREAlso: Supersonic Imagine | Radiation | Diagnosis of deep vein thrombosis |
Primary outcome
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
3 secondary outcomes
Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated
Time frame: Day 0, Day 7, Day 30
Thrombus properties if provoked versus unprovoked thrombosis
Time frame: 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
Time frame: Day 0, Day 7, Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles PERNOD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elastography SWIRE in people with Deep Vein Thrombosis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles PERNOD (00 334 767 657 17, GPernod@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.