Venous Thromboembolic DiseaseCoMTEVNCT07016542
Cohort for Monitoring Patients With Venous Thromboembolic Disease
An observational study of Venous Thromboembolic Disease, run by University Hospital, Rouen at 1 site in France.
Trial summary
Venous thromboembolic disease is a common pathology in the general population (1.5/1000), the prognosis of which depends in particular on the risk of recurrence. This risk depends essentially on whether the thrombotic episode was provoked or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolic Disease
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2019to 1 Jun 2032
- How long will I take part?
- 12 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient having experienced at least one venous thromboembolic episode
Who may be able to join
- Any patient over 18 years of age who has experienced at least one venous thromboembolic episode:
- Deep vein thrombosis confirmed by Doppler ultrasound or CT venography,
- Pulmonary embolism confirmed by CT angiography, ventilation/perfusion scan, or confirmed DVT episode with respiratory signs consistent with PE.
- Hospitalization in the Internal Medicine Department
- Consultation by an Internal Medicine physician
- File presented at the thrombosis multidisciplinary meeting
Who cannot join
- Thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Rouen
Rouen, 76031
Sébastien SM MIRANDA, Doctor, 02 32 88 90 01 ext. +33, Sebastien.Miranda@chu-rouen.fr
About this study
Venous thromboembolic disease is a common pathology in the general population (1.5/1000), the prognosis of which depends in particular on the risk of recurrence. This risk depends essentially on whether the thrombotic episode was provoked or not. Thus, patients who present a thromboembolic event without any contributing factor have a high risk of recurrence, which encourages clinicians to continue anticoagulant treatment for a long time. However, anticoagulant treatment is the leading cause of hospitalization for iatrogenic causes and the leading cause of iatrogenic mortality. The benefit-risk balance of treatment must be evaluated regularly, which requires a good knowledge of the risk factors for thrombotic recurrence and the risk factors for hemorrhage.
Read the detailed description
Several tools have been established and validated to help clinicians assess patients' bleeding risk, notably using the HAS BLED, haemorrage, and more recently the VTE BLED score. This latest score, published very recently, is the only one to have been validated in patients treated with direct oral anticoagulants. At the same time, we have recurrence risk scores such as HERDOO2, which allow us to identify patients at low risk of recurrence.
In order to improve the management of patients with venous thromboembolic disease, multidisciplinary thrombosis RCPs have been established since 2015, bringing together hemostasis specialists, internists, oncologists, and private vascular physicians to assist clinicians in managing complex cases. • Dedicated post-emergency consultations twice a week to streamline outpatient care for less serious patients This study aims to evaluate the effectiveness of these tools: score and RCP in the management of patients with venous thromboembolic disease.
- Conditions
- Venous Thromboembolic Disease
- Keywords
- risk of thrombotic recurrence, hemorrhagic risk factors
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 |
|---|---|---|
| Patient having experienced at least one venous thromboembolic episode | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence in patients treated with venous thromboembolic disease (VTE)
Evaluation of the number of hospitalizations or consultations for a venous thrombotic recurrence
Measured: 12 years
Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE)
Evaluation of the number of hospitalizations or consultations for a hemorrhagic complication.
Measured: 12 years
Secondary outcomes (2)
Long-term complication rates
Assessment of the occurrence of long-term complications
Measured: At enrollment visit, 6 months, 1 years and each year during 12 years
Long-term complication rates
Assessment of mortality
Measured: At enrollment visit, 6 months, 1 years and each year during 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start18 Nov 2019
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Jun 2032 (estimated)
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, RouenThe 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
- 2,000 participants (estimated)
- Target duration
- 12 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien SM MIRANDA, Doctor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016542
- Sponsor's protocol ID
- 2018/352/OB
- Other IDs
- ID RCB : 2018-A02844-51
- Acronym
- CoMTEV
- Status last verified
- Jan 2025
- First submitted
- 4 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort for Monitoring Patients With Venous Thromboembolic Disease
- ClinicalTrials.gov ID
- NCT07016542
- Acronym / sponsor ID
- CoMTEV / 2018/352/OB
- Conditions
- Venous Thromboembolic Disease
- Keywords
- risk of thrombotic recurrence, hemorrhagic risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 11 Jun 2025 (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 thromboembolic disease is a common pathology in the general population (1.5/1000), the prognosis of which depends in particular on the risk of recurrence. This risk depends essentially on whether the thrombotic episode was provoked or not. Thus, patients who present a thromboembolic event without any contributing factor have a high risk of recurrence, which encourages clinicians to continue anticoagulant treatment for a long time. However, anticoagulant treatment is the leading cause of hospitalization for iatrogenic causes and the leading cause of iatrogenic mortality. The benefit-risk balance of treatment must be evaluated regularly, which requires a good knowledge of the risk factors for thrombotic recurrence and the risk factors for hemorrhage.
Detailed description
Several tools have been established and validated to help clinicians assess patients' bleeding risk, notably using the HAS BLED, haemorrage, and more recently the VTE BLED score. This latest score, published very recently, is the only one to have been validated in patients treated with direct oral anticoagulants. At the same time, we have recurrence risk scores such as HERDOO2, which allow us to identify patients at low risk of recurrence.
In order to improve the management of patients with venous thromboembolic disease, multidisciplinary thrombosis RCPs have been established since 2015, bringing together hemostasis specialists, internists, oncologists, and private vascular physicians to assist clinicians in managing complex cases. • Dedicated post-emergency consultations twice a week to streamline outpatient care for less serious patients This study aims to evaluate the effectiveness of these tools: score and RCP in the management of patients with venous thromboembolic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient having experienced at least one venous thromboembolic episode | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having experienced at least one venous thromboembolic episode
Key inclusion criteria (6 listed)
- Any patient over 18 years of age who has experienced at least one venous thromboembolic episode:
- Hospitalization in the Internal Medicine Department
- Consultation by an Internal Medicine physician
- File presented at the thrombosis multidisciplinary meeting
Key exclusion criteria (1 listed)
- Thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)
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
Rate of recurrence in patients treated with venous thromboembolic disease (VTE)
Time frame: 12 years
Evaluation of the number of hospitalizations or consultations for a venous thrombotic recurrence
Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE)
Time frame: 12 years
Evaluation of the number of hospitalizations or consultations for a hemorrhagic complication.
2 secondary outcomes
Long-term complication rates
Time frame: At enrollment visit, 6 months, 1 years and each year during 12 years
Long-term complication rates
Time frame: At enrollment visit, 6 months, 1 years and each year during 12 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Yes. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
Sébastien SM MIRANDA, Doctor principal investigator
University Hospital, Rouen
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, Rouen 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 6 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: looking for participants now, as of the sponsor's last update on 11 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David DM MALLET, Director (02 32 88 82 65 ext. +33, David.Mallet@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence in patients treated with venous thromboembolic disease (VTE) (time frame: 12 years). 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 11 Jun 2025.