Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biologic sample.
- Who it may be relevant to
- Registry conditions: Thromboembolic Venous Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte
Overview
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
- Biological Biologic sample
Biological samples will be taken from the subjects included
Primary outcome measures
- Recurrence of thromboembolic venous disease [Time frame: 20 years]
Secondary outcome measures (4)
- Haemorrhages under anticoagulant [Time frame: 20 years]
- Mortality [Time frame: 20 years]
- Arterial complications [Time frame: 20 years]
- Long-term complications [Time frame: 20 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 4 centers
- CHRU Brest — Brest
- HIA Clermont Tonnerre Brest — Brest
- CH Morlaix — Morlaix
- CH de Cornouaille — Quimper
Identifiers
NCT: NCT04297085 · BREIZH-Cohorte (29BRC19.0304)