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NCT Number: NCT04297085

Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brest, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biologic sample

Biological

Biological samples will be taken from the subjects included

Primary outcomes

  1. Recurrence of thromboembolic venous disease

    Time frame: 20 years

    Recurrence of thromboembolic venous disease will be established at the end of patient monitoring

Secondary outcomes

  1. Haemorrhages under anticoagulant

    Time frame: 20 years

    Haemorrhages under anticoagulant will be identified during patient follow-up

  2. Mortality

    Time frame: 20 years

    Mortality will be identified during patient follow-up

  3. Arterial complications

    Time frame: 20 years

    Arterial complications will be identified during patient follow-up

  4. Long-term complications

    Time frame: 20 years

    long-term complications (chronic thrombo-embolic pulmonary hypertension, chronic thrombo-embolic disease) will be identified during patient follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Francis COUTURAUD, MD, PHD

CONTACT

[email protected]

02 98 34 73 47 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: BREIZH-Cohorte

Important dates

Study start
2020
Primary completion
2050
Study completion
2050
First posted
Mar 5, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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