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Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04297085
Acronym
BREIZH-Cohorte
Enrollment
3400
Registered
2020-03-05
Start date
2020-05-28
Completion date
2050-04-01
Last updated
2026-06-15

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

Conditions

Thromboembolic Venous Disease

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.

Interventions

BIOLOGICALBiologic sample

Biological samples will be taken from the subjects included

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of thromboembolic venous disease20 yearsRecurrence of thromboembolic venous disease will be established at the end of patient monitoring

Secondary

MeasureTime frameDescription
Haemorrhages under anticoagulant20 yearsHaemorrhages under anticoagulant will be identified during patient follow-up
Mortality20 yearsMortality will be identified during patient follow-up
Arterial complications20 yearsArterial complications will be identified during patient follow-up
Long-term complications20 yearslong-term complications (chronic thrombo-embolic pulmonary hypertension, chronic thrombo-embolic disease) will be identified during patient follow-up

Countries

France

Contacts

CONTACTFrancis COUTURAUD, MD, PHD
francis.couturaud@chu-brest.fr02 98 34 73 47
PRINCIPAL_INVESTIGATORFrancis COUTURAUD, MD, PHD

EA3878 (GETBO), Brest University Hospital in France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026