Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence

Thromboembolic Venous Disease Clinical Trial

— BREIZH-Cohorte  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04297085
• Other study ID #: BREIZH-Cohorte (29BRC19.0304)
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: April 2050

Study information

• Verified date: March 2020
• Source: University Hospital, Brest
• Contact: Francis COUTURAUD, MD, PHD
• Phone: 02 98 34 73 47
• Email: francis.couturaud[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3400
• Est. completion date: April 2050
• Est. primary completion date: April 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

• Under 50 or any age if active cancer

• Affiliated to social security

• Accepting to participate in the study.

Exclusion Criteria:

• Foreign nationality.

• Inability to communicate (comprehension disorder).

• Refusal to participate.

Related Conditions & MeSH terms

• Recurrence
• Thromboembolic Venous Disease

Intervention

Biological:
• Biologic sample
Biological samples will be taken from the subjects included

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of thromboembolic venous disease	Recurrence of thromboembolic venous disease will be established at the end of patient monitoring	20 years
Secondary	Haemorrhages under anticoagulant	Haemorrhages under anticoagulant will be identified during patient follow-up	20 years
Secondary	Mortality	Mortality will be identified during patient follow-up	20 years
Secondary	Arterial complications	Arterial complications will be identified during patient follow-up	20 years