Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence (BREIZH-Cohorte)

Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte

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).

Study Overview

• Status: Recruiting
• Conditions: Thromboembolic Venous Disease
• Intervention / Treatment: Biological: Biologic sample

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.

• Study Type: Interventional
• Enrollment (Estimated): 3400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis COUTURAUD, MD, PHD; Phone Number: +33 02 98 34 73 47; Email: francis.couturaud@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHRU Brest
    • Contact: Francis Couturaud, Professor; Phone Number: +33 02 98 34 73 47; Email: francis.couturaud@chu-brest.fr
  • Brest, France, 29200
    • Recruiting
    • HIA Clermont Tonnerre Brest
    • Contact: Marc DANGUY DES DESERTS
  • Morlaix, France, 29672
    • Recruiting
    • CH Morlaix
    • Contact: Yannick LAMBERT
  • Quimper, France, 29107
    • Recruiting
    • CH de Cornouaille
    • Contact: Lenaïg LE CLECH; Phone Number: 02 98 52 67 31

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cases	Biological: Biologic sample; Biological samples will be taken from the subjects included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of thromboembolic venous disease	Recurrence of thromboembolic venous disease will be established at the end of patient monitoring	20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemorrhages under anticoagulant	Haemorrhages under anticoagulant will be identified during patient follow-up	20 years
Mortality	Mortality will be identified during patient follow-up	20 years
Arterial complications	Arterial complications will be identified during patient follow-up	20 years
Long-term complications	long-term complications (chronic thrombo-embolic pulmonary hypertension, chronic thrombo-embolic disease) will be identified during patient follow-up	20 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Francis COUTURAUD, MD, PHD, EA3878 (GETBO), Brest University Hospital in France

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Estimated): April 1, 2050
• Study Completion (Estimated): April 1, 2050

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: BREIZH-Cohorte (29BRC19.0304)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No