Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence

NCT ID: NCT04297085

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2050-04-30

Brief Summary

The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).

Detailed Description

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are two clinical manifestations of the same entity, thromboembolic venous disease. This disease is frequent: the annual incidence of thromboembolic venous disease estimated between 1 and 2 cases per 1000 inhabitants per year in France, comparable to that observed in North America. This disease is potentially serious: the mortality from PE, the most severe manifestation of thromboembolic venous disease (one third of PE for two thirds of DVT) is 10% at 3 months, twice as high as that of myocardial infarction. However, the risk of PE in isolated DVT is major (more than 50% of cases). Thus, whether it is a PE or a DVT, anticoagulant treatment, a cornerstone of therapeutic management, must therefore be initiated urgently, without waiting for the results of diagnostic confirmatory examinations.

The major complications occurring after a thromboembolic venous disease are venous thromboembolic recurrence (VTE) and the long-term consequences: post-thrombotic syndrome and the development of post-embolic pulmonary hypertension. VTE recurrence has significant mortality, particularly in the form of PE (15%, compared to 2% in the form of DVT). As for long-term complications of VTE, about 20-30% of patients with DVT develop post-thrombotic syndrome at 5 years (27), while 0.15% to 5% of patients with PE develop post-embolic pulmonary hypertension at 1 year.

While major progress has been made over the past 20 years in terms of diagnosis, primary and secondary prevention, identification of risk factors for VTE and prognostic factors, however, two particular subgroups deserve to be specifically investigated: young subjects, whether women (hormonal exposure) or men (often idiopathic thromboembolic venous disease), and cancer patients. In the latter, the progress made on anti-cancer treatments is helping to modify the data on the risk of VTE as well as the duration of treatment of VTE in these patients.

Thus, this prospective cohort covers two subgroups of patients with thromboembolic venous disease: young subjects (≤50 years) or those who have cancer.

Conditions

Thromboembolic Venous Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cases

Group Type: EXPERIMENTAL

Biologic sample

Intervention Type: BIOLOGICAL

Biological samples will be taken from the subjects included

Interventions

Biologic sample

Biological samples will be taken from the subjects included

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subject aged 18 or over, or a minor with the consent of the parents and the minor, presenting with a thromboembolic venous disease
• 50 and under or any age if active cancer
• Affiliated to social security
• Accepting to participate in the study.

Exclusion Criteria

• Inability to communicate (comprehension disorder).
• Refusal to participate.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis COUTURAUD, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

EA3878 (GETBO), Brest University Hospital in France

Locations

CHRU Brest

Brest, , France

Site Status: RECRUITING

HIA Clermont Tonnerre Brest

Brest, , France

Site Status: RECRUITING

CH Morlaix

Morlaix, , France

Site Status: RECRUITING

CH de Cornouaille

Quimper, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Francis COUTURAUD, MD, PHD

Role: CONTACT

francis.couturaud@chu-brest.fr

02 98 34 73 47 ext. +33

Facility Contacts

Francis Couturaud, Professor

Role: primary

francis.couturaud@chu-brest.fr

02 98 34 73 47 ext. +33

Marc DANGUY DES DESERTS

Role: primary

Yannick LAMBERT

Role: primary

Lenaïg LE CLECH

Role: primary

02 98 52 67 31

Other Identifiers

BREIZH-Cohorte (29BRC19.0304)

Identifier Type: -

Identifier Source: org_study_id