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Cohort for Monitoring Patients With Venous Thromboembolic Disease

Cohort for Monitoring Patients With Venous Thromboembolic Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07016542
Acronym
CoMTEV
Enrollment
2000
Registered
2025-06-11
Start date
2019-11-18
Completion date
2032-06-01
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolic Disease

Keywords

risk of thrombotic recurrence, hemorrhagic risk factors

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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. 2. Hospitalization in the Internal Medicine Department 3. Consultation by an Internal Medicine physician 4. File presented at the thrombosis multidisciplinary meeting

Exclusion criteria

Thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)

Design outcomes

Primary

MeasureTime frameDescription
Rate of recurrence in patients treated with venous thromboembolic disease (VTE)12 yearsEvaluation of the number of hospitalizations or consultations for a venous thrombotic recurrence
Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE)12 yearsEvaluation of the number of hospitalizations or consultations for a hemorrhagic complication.

Secondary

MeasureTime frameDescription
Long-term complication ratesAt enrollment visit, 6 months, 1 years and each year during 12 yearsAssessment of the occurrence of long-term complications

Countries

France

Contacts

Primary ContactDavid DM MALLET, Director
David.Mallet@chu-rouen.fr02 32 88 82 65
Backup ContactVincent VF FERRANTI, ARC
Vincent.Ferranti@chu-rouen.fr02 32 88 82 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026