Venous ThromboembolismTEVTENCT04130048
Thrombus Elastography in Venous Thrombo-Embolism.
An observational study of Venous Thromboembolism, run by University Hospital, Brest at 1 site in France.
Trial summary
Venous Thrombo-Embolic Disease (VTED) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Ultrasound Elastography
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2019to 14 Dec 2019
- Phase
- Observational
- 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
Study population: Any patient suffering from a proximal DVT (DVT) of at least one lower limb and admitted to the vascular medicine department of the Brest University Hospital.
Who may be able to join
- Over 18 years old.
- Suffering from a proximal DVT (DVT) of at least one lower limb.
- Thrombosis is assumed to be recent (no history of ipsilateral DVT).
- Non opposition obtained.
Who cannot join
- Patient suffering from an inferior vena cava thrombosis with no extension to ilio-femoral veins.
- Physical or cognitive inability to consent.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Brest University Hospital
Brest, Finistere, 29200
Luc Bressollette, luc.bressollette@chu-brest.fr
About this study
Official title: Assessment of Thrombus Stiffness Using Ultrasound Elastography in Venous Thrombo-embolism.
Venous Thrombo-Embolic Disease (VTED) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. It represents the third cause of death after cardio-vascular disease and cancer, and encompass superficial, muscular and Deep Venous Thrombosis (DVT), and Pulmonary Embolisms (PE), which can be isolated or associated.
Ultrasound is today the most frequently used exam to diagnose DVT. However, it's unable to provide information on thrombus age or cause.
Elastography is an imaging technic which aims to analyse elastic properties of a tissue, by applying a mechanical impulse on it, and could be an interesting tool in thrombus exploration, and provide additional information.
Read the detailed description
Proximal deep venous thrombosis of a lower limb was defined as any venous thrombosis involving the ilio-femoral and/or femoro-popliteal axes, with or without cava thrombosis or distal DVT.
A DVT was assumed provoked, as recommended by AFSSAPS (2009) and ACCP (2012), when there was a major transient risk factor (surgery, prolonged immobilization ≥3 days, lower limb fracture) in the last three months, or a persistent risk factor (Antiphospholipid syndrome, active cancer). In case of absence of at least one of these factors, DVT was considered unprovoked.
A DVT was supposed recent when there was no known DVT in the patient medical history.
The association with a Pulmonary Embolism was assessed by the presence of PE diagnosis in the medical report. It had to be diagnosed following the ESC guidelines, with a thoracic CT scan and/or a V/Q lung scan.
In this study, we analysed the shear wave's velocity (expressed in m/s).
Acquisitions were obtained during the venous ultrasound realised for the diagnosis of DVT. All measures were made on the same ultrasonic device, with the ShearWave module.
- Conditions
- Venous Thromboembolism
- Being tested
- Ultrasound Elastography
- Keywords
- Elasticity Imaging Techniques, Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ElastographyDiagnostic test
Ultrasound elastography aims to assess the stiffness of a tissue, submitting it to an ultrasound impulse.
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Speed within the thrombus.
Quantitative data, in meter per second.
Measured: At VTE diagnostic (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start10 Oct 2019
- Primary completion14 Dec 2019 (estimated)
- Study completion14 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130048
- Sponsor's protocol ID
- TEVTE ( 29BRC19. 101)
- Acronym
- TEVTE
- Status last verified
- May 2019
- First submitted
- 15 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thrombus Stiffness Using Ultrasound Elastography in Venous Thrombo-embolism.
- ClinicalTrials.gov ID
- NCT04130048
- Acronym / sponsor ID
- TEVTE / TEVTE ( 29BRC19. 101)
- Conditions
- Venous Thromboembolism
- Keywords
- Elasticity Imaging Techniques, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 14 Dec 2019 (estimated)
- Study completion
- 14 Dec 2019 (estimated)
- First posted
- 17 Oct 2019 (actual)
- 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.
Venous Thrombo-Embolic Disease (VTED) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. It represents the third cause of death after cardio-vascular disease and cancer, and encompass superficial, muscular and Deep Venous Thrombosis (DVT), and Pulmonary Embolisms (PE), which can be isolated or associated.
Ultrasound is today the most frequently used exam to diagnose DVT. However, it's unable to provide information on thrombus age or cause.
Elastography is an imaging technic which aims to analyse elastic properties of a tissue, by applying a mechanical impulse on it, and could be an interesting tool in thrombus exploration, and provide additional information.
Detailed description
Proximal deep venous thrombosis of a lower limb was defined as any venous thrombosis involving the ilio-femoral and/or femoro-popliteal axes, with or without cava thrombosis or distal DVT.
A DVT was assumed provoked, as recommended by AFSSAPS (2009) and ACCP (2012), when there was a major transient risk factor (surgery, prolonged immobilization ≥3 days, lower limb fracture) in the last three months, or a persistent risk factor (Antiphospholipid syndrome, active cancer). In case of absence of at least one of these factors, DVT was considered unprovoked.
A DVT was supposed recent when there was no known DVT in the patient medical history.
The association with a Pulmonary Embolism was assessed by the presence of PE diagnosis in the medical report. It had to be diagnosed following the ESC guidelines, with a thoracic CT scan and/or a V/Q lung scan.
In this study, we analysed the shear wave's velocity (expressed in m/s).
Acquisitions were obtained during the venous ultrasound realised for the diagnosis of DVT. All measures were made on the same ultrasonic device, with the ShearWave module.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient suffering from a proximal DVT (DVT) of at least one lower limb and admitted to the vascular medicine department of the Brest University Hospital.
Key inclusion criteria (4 listed)
- Over 18 years old.
- Suffering from a proximal DVT (DVT) of at least one lower limb.
- Thrombosis is assumed to be recent (no history of ipsilateral DVT).
- Non opposition obtained.
Key exclusion criteria (3 listed)
- Patient suffering from an inferior vena cava thrombosis with no extension to ilio-femoral veins.
- Physical or cognitive inability to consent.
- Patient refusal.
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 |
|---|---|---|
| Ultrasound ElastographyUltrasound elastography aims to assess the stiffness of a tissue, submitting it to an ultrasound impulse. | Diagnostic test | – |
Primary outcome
Shear Wave Speed within the thrombus.
Time frame: At VTE diagnostic (Day 0)
Quantitative data, in meter per second.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by University Hospital, Brest 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 4 inclusion and 3 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 17 Oct 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 Luc BRESSOLLETTE (02-98-34-73-42, luc.bressollette@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Speed within the thrombus. (time frame: At VTE diagnostic (Day 0)). 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 17 Oct 2019.