SurveyObserv-MTEVNCT04272723
Management of Venous Thromboembolism in France: a National Survey Among Vascular Medicine Physicians
An observational study of Survey and Venous Thromboembolism, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survey, Venous Thromboembolism, Deep Vein Thrombosis
- How many people
- 383 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2019to 1 Jul 2023
- 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: Vascular medicine physicians (VMP) practicing in the hospital and in the community settings. Participating VMP will prospectively collect data on the management of incident venous thromboembolic (VTE) disease cases. After that, vascular medicine physicians will answer a phone questionnaire on their general VTE management
Who may be able to join
- vascular medicine physicians who are active members of the SFMV (French Society of Vascular Medicine)
- vascular medicine physicians registered as willing to do medical research
Who cannot join
- vascular medicine physicians who refuse to provide consent
- vascular medicine physicians who are retired
- non-practicing vascular medicine physicians
Trial locations and contacts
1 site in 1 country.
About this study
In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Since then a large number of practice changing studies have been published. This includes trials that have validated the use of direct oral anticoagulants (DOAC), the new standard of care of VTE, as per new national and international guidelines. Management of VTE in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. It is therefore important to have an update on the routine clinical practice management of VTE by VMP. In this perspective the investigators aim to conduct a national survey among VMP practicing in France
- Keywords
- Survey, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Anticoagulant, Clinical Practice, Therapeutic management
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VMP members of the SFMV | VMP (vascular medicine physicians) members of the SFMV (French Society of Vascular Medicine ) | |
| VMP registered as willing to do medical research | VMP (vascular medicine physicians) registered as willing to do medical research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-practician variability of clinical care of venous thromboembolic in routine clinical practice
The variation in venous thromboembolic management in routine clinical practice is assessed by analysing the management of the 5 consecutive acute venous thromboembolic patients reported by each participating physician
Measured: up to 3 months after inclusion
Secondary outcomes (3)
Inter-practician variability of clinical care of venous thromboembolic according to patient age
patient characteristics are : cancer, extreme body weight, severe renal impairment, elderly or pregnant patients, high bleeding risk
Measured: up to 6 months after inclusion
Inter-practician variability of clinical care of venous thromboembolic according to patient body weight
patient characteristics are : cancer, extreme body weight, severe renal impairment, elderly or pregnant patients, high bleeding risk
Measured: up to 6 months after inclusion
Inter-practician variability of clinical care of venous thromboembolic according to patient bleeding risk
patient characteristics are : cancer, extreme body weight, severe renal impairment, elderly or pregnant patients, high bleeding risk
Measured: up to 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start21 Aug 2019
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurveyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Soudet, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272723
- Sponsor's protocol ID
- PI2020_843_0014
- Acronym
- Observ-MTEV
- Status last verified
- Jul 2023
- First submitted
- 13 Feb 2020
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Venous Thromboembolism in France: a National Survey Among Vascular Medicine Physicians
- ClinicalTrials.gov ID
- NCT04272723
- Acronym / sponsor ID
- Observ-MTEV / PI2020_843_0014
- Keywords
- Survey, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Anticoagulant, Clinical Practice, Therapeutic management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Feb 2020 (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.
In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Since then a large number of practice changing studies have been published. This includes trials that have validated the use of direct oral anticoagulants (DOAC), the new standard of care of VTE, as per new national and international guidelines. Management of VTE in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. It is therefore important to have an update on the routine clinical practice management of VTE by VMP. In this perspective the investigators aim to conduct a national survey among VMP practicing in France
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VMP members of the SFMV | – | –VMP (vascular medicine physicians) members of the SFMV (French Society of Vascular Medicine ) |
| VMP registered as willing to do medical research | – | –VMP (vascular medicine physicians) registered as willing to do medical research |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vascular medicine physicians (VMP) practicing in the hospital and in the community settings. Participating VMP will prospectively collect data on the management of incident venous thromboembolic (VTE) disease cases. After that, vascular medicine physicians will answer a phone questionnaire on their general VTE management
Key inclusion criteria (2 listed)
- vascular medicine physicians who are active members of the SFMV (French Society of Vascular Medicine)
- vascular medicine physicians registered as willing to do medical research
Key exclusion criteria (3 listed)
- vascular medicine physicians who refuse to provide consent
- vascular medicine physicians who are retired
- non-practicing vascular medicine physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-practician variability of clinical care of venous thromboembolic in routine clinical practice
Time frame: up to 3 months after inclusion
The variation in venous thromboembolic management in routine clinical practice is assessed by analysing the management of the 5 consecutive acute venous thromboembolic patients reported by each participating physician
3 secondary outcomes
Inter-practician variability of clinical care of venous thromboembolic according to patient age
Time frame: up to 6 months after inclusion
Inter-practician variability of clinical care of venous thromboembolic according to patient body weight
Time frame: up to 6 months after inclusion
Inter-practician variability of clinical care of venous thromboembolic according to patient bleeding risk
Time frame: up to 6 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- 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.
Simon Soudet, MD principal investigator
CHU Amiens
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 Survey and Venous Thromboembolism, run by Centre Hospitalier Universitaire, Amiens 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 2 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: finished, as of the sponsor's last update on 12 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-practician variability of clinical care of venous thromboembolic in routine clinical practice (time frame: up to 3 months after inclusion). 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 12 Jul 2023.