Cohort for Monitoring Patients With Venous Thromboembolic Disease

NCT ID: NCT07016542

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2032-06-01

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.

Conditions

Venous Thromboembolic Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient having experienced at least one venous thromboembolic episode

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien SM MIRANDA, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

University Hospital of Rouen

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David DM MALLET, Director

Role: CONTACT

David.Mallet@chu-rouen.fr

02 32 88 82 65 ext. +33

Vincent VF FERRANTI, ARC

Role: CONTACT

Vincent.Ferranti@chu-rouen.fr

02 32 88 82 65 ext. +33

Facility Contacts

Sébastien SM MIRANDA, Doctor

Role: primary

Sebastien.Miranda@chu-rouen.fr

02 32 88 90 01 ext. +33

Other Identifiers

ID RCB : 2018-A02844-51

Identifier Type: OTHER

Identifier Source: secondary_id

2018/352/OB

Identifier Type: -

Identifier Source: org_study_id