Cardiovascular and Venous Thromboembolism Disease in Patients with Von Willebrand Disease in the French West

NCT ID: NCT05773638

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-26

Study Completion Date

2026-12-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Due to increasing of life expectancy, patients with von Willebrand disease are exposed to age-related pathologies such as cancer or cardiovascular diseases. Management of thrombotic events is challenging given the inherent bleeding risk in von Willebrand disease. Few data are currently available in the literature.

The aim of the study is to describe the frequency and nature of arterial and venous thromboembolic events and atrial fibrillation in patients with von Willebrand disease in the West of France.

The investigators will perform a retrospective multicenter study conducted in the von Willebrand population of the French West. Von Willebrand adult patients followed in one of the French West medical centers participating in the study, who presented deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, acute coronary syndrome, acute limb ischemia, atrial fibrillation, arteriopathy of the lower limbs, angina will be eligible.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Von Willebrand disease is the most common hereditary bleeding disorder. Due to the development of therapies, life expectancy and life quality are increasing in affected patients. However, certain treatments and/or certain comorbidities associated with venous and arterial thrombotic risks may be present in these patients. In the general population, venous thromboembolic disease, arterial thrombosis and atrial fibrillation are frequent. Their management requires the use of antiaggregants and anticoagulant molecules, themselves associated with a bleeding risk. Few data are currently available in the literature concerning the occurrence of venous and arterial thromboembolic events in patients with von Willebrand disease and their management, in the face of a hemorrhagic risk inherent to their pathology and its increase by anti-aggregant treatments and anticoagulants.

The aim of the study is to describe the frequency and nature of arterial and venous thromboembolic events and atrial fibrillation in patients with von Willebrand disease in the West of France.

The investigators will perform a retrospective multicenter study on data conducted in the French West. The study population is composed of patients with von Willebrand disease followed in a reference center in the French West, have consented to be included in the BERHLINGO database (Base d'Etude et de Recherche pour Les INvestigateurs en Hémostase du Grand-Ouest), and who presented deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, acute coronary syndrome, acute limb ischemia, atrial fibrillation, arteriopathy of the lower limbs, angina. Data about von Willebrand disease, risk factors, event, treatment such as antiaggregants and anticoagulants and complications such as hemorrhage or recurrence, will be collected.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Von Willebrand Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Von Willebrand disease
* Adult
* Followed-up in a reference center of West of France (Caen, Brest, Nantes, Rennes, Le Mans, Angers)
* Consented to be included in BERHLINGO database
* Have presented a thrombotic and/or embolic event or cardiovascular disease including deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, acute coronary syndrome, acute limb ischemia or angina or obliterating arteriopathy of the lower limbs, atrial fibrillation.
* Have not expressed their opposition

Exclusion Criteria

* \- Expression of opposition
* Acquired von Willebrand syndrome
* Patients under legal protection
* Minor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU d'Angers

Angers, , France

Site Status NOT_YET_RECRUITING

CHU de Brest

Brest, , France

Site Status RECRUITING

CHU de Caen

Caen, , France

Site Status NOT_YET_RECRUITING

CH le MANS

Le Mans, , France

Site Status NOT_YET_RECRUITING

CHU de Nantes

Nantes, , France

Site Status NOT_YET_RECRUITING

CHU de Rennes

Rennes, , France

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Brigitte PAN PETESCH

Role: CONTACT

02.98.22.36.50

Sara ROBIN

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Philippe BEURRIER

Role: primary

Brigitte PAN PETESCH

Role: primary

Yohann REPESSE

Role: primary

Vincent CUSSAC

Role: primary

Marc TROSSAERT

Role: primary

Benoit GUILLET

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TWIGO ( 29BRC21.0204)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.