Venous Thromboembolic DiseaseREMOTEVNCT02188056
Observational Prospectif Monocentric Registry of Patients Suffering From VIE
An observational study of Venous Thromboembolic Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolic Disease
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2014to 31 Aug 2017
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a venous thromboembolic event, hospitalized in the Department of Vascular Diseases and Hypertension, UF 1311 will included in the registry prospectively.
Who may be able to join
- diagnosis of venous thromboembolism established by a validated test (venous Doppler ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation / perfusion),
- diagnosis of venous thromboembolism made within 15 days,
- the previous inclusion in the register (outpatient or inpatient)
Who cannot join
- person doesn't wish to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Venous, Thromboembolic, Pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of recurrent thromboembolic
Measured: at 1 year post-diagnosis
bleeding complications incidence
Measured: at 1 year post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study start1 Oct 2014
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique STEPHAN, MD, PhD, Principal investigator, Strasbourg University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188056
- Sponsor's protocol ID
- 003-14
- Acronym
- REMOTEV
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospectif Monocentric Registry of Patients Suffering From VIE
- ClinicalTrials.gov ID
- NCT02188056
- Acronym / sponsor ID
- REMOTEV / 003-14
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Venous, Thromboembolic, Pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2014
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 11 Jul 2014 (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.
Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a venous thromboembolic event, hospitalized in the Department of Vascular Diseases and Hypertension, UF 1311 will included in the registry prospectively.
Key inclusion criteria (3 listed)
- diagnosis of venous thromboembolism established by a validated test (venous Doppler ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation / perfusion),
- diagnosis of venous thromboembolism made within 15 days,
- the previous inclusion in the register (outpatient or inpatient)
Key exclusion criteria (1 listed)
- person doesn't wish to participate in this study
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
incidence of recurrent thromboembolic
Time frame: at 1 year post-diagnosis
bleeding complications incidence
Time frame: at 1 year post-diagnosis
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 5 Sep 2025.
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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.
Dominique STEPHAN, MD, PhD principal investigator
Strasbourg University Hospital, France
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 Thromboembolic Disease, run by University Hospital, Strasbourg, France 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 1 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 5 Sep 2025. 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?
incidence of recurrent thromboembolic (time frame: at 1 year post-diagnosis). The study lists 2 primary outcomes in all. 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 5 Sep 2025.