Clinical trial NCT07016542: Cohort for Monitoring Patients With Venous Thromboembolic Disease
Official title: Cohort for Monitoring Patients With Venous Thromboembolic Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolic Disease
Keywords: risk of thrombotic recurrence
hemorrhagic risk factors
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient having experienced at least one venous thromboembolic episode

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of recurrence in patients treated with venous thromboembolic disease (VTE)
timeFrame: 12 years
measure: Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE)
timeFrame: 12 years
Secondary outcomes:
measure: Long-term complication rates
timeFrame: At enrollment visit, 6 months, 1 years and each year during 12 years
measure: Long-term complication rates
timeFrame: At enrollment visit, 6 months, 1 years and each year during 12 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Sébastien SM MIRANDA, Doctor
role: PRINCIPAL_INVESTIGATOR
References: