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

Primary Purpose

Thromboembolic Venous Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biologic sample
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thromboembolic Venous Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU Brest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cases

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Haemorrhages under anticoagulant
Haemorrhages under anticoagulant will be identified during patient follow-up
Mortality
Mortality will be identified during patient follow-up
Arterial complications
Arterial complications will be identified during patient follow-up

Full Information

First Posted
March 4, 2020
Last Updated
March 4, 2020
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04297085
Brief Title
Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence
Acronym
BREIZH-Cohorte
Official Title
Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
April 2050 (Anticipated)
Study Completion Date
April 2050 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolic Venous Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cases
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Biologic sample
Intervention Description
Biological samples will be taken from the subjects included
Primary Outcome Measure Information:
Title
Recurrence of thromboembolic venous disease
Description
Recurrence of thromboembolic venous disease will be established at the end of patient monitoring
Time Frame
20 years
Secondary Outcome Measure Information:
Title
Haemorrhages under anticoagulant
Description
Haemorrhages under anticoagulant will be identified during patient follow-up
Time Frame
20 years
Title
Mortality
Description
Mortality will be identified during patient follow-up
Time Frame
20 years
Title
Arterial complications
Description
Arterial complications will be identified during patient follow-up
Time Frame
20 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis COUTURAUD, MD, PHD
Phone
02 98 34 73 47
Ext
+33
Email
francis.couturaud@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD, MD, PHD
Organizational Affiliation
EA3878 (GETBO), Brest University Hospital in France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Couturaud, Professor
Phone
02 98 34 73 47
Ext
+33
Email
francis.couturaud@chu-brest.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence

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