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

NCT05773638 | Recruiting

• 1 other identifier: TWIGO ( 29BRC21.0204)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Von Willebrand Diseases

Keywords

von Willebrand disease; venous thromboembolism disease; cardiovascular disease; atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• To describe the frequency of arterial and venous thromboembolic events and cardiac arrhythmia due to atrial fibrillation in patients with Willebrand disease in the Greater West.

  Occurrence of a thromboembolic event validated by an adjudication committee

  12 months

• To describe the nature of arterial and venous thromboembolic events and cardiac arrhythmia due to atrial fibrillation in patients with Willebrand disease in the Greater West.

  Occurrence of a thromboembolic event validated by an adjudication committee

  12 months

Secondary Outcomes (7)

• Identify potential risk factors

  12 months

• Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions

  12 months

• Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants

  12 months

• Evaluate the tolerance of these treatments

  12 months

• Evaluate the effectiveness of these treatments

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with von Willebrand disease followed in a reference center in the French West and who have consented to be included in the BERHLINGO database (Base d'Etude et de Recherche pour Les INvestigateurs en Hémostase du Grand-Ouest) with a medical history of deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, acute coronary syndrome, acute limb ischemia, angina, obliterating arteriopathy of the lower limbs or atrial fibrillation.

You may qualify if:

• 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

You may not qualify if:

• \- Expression of opposition
• Acquired von Willebrand syndrome
• Patients under legal protection
• Minor

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (6)

CHU d'Angers

Angers, 49933, France

NOT YET RECRUITING

CHU de Brest

Brest, 29609, France

RECRUITING

CHU de Caen

Caen, 14033, France

NOT YET RECRUITING

CH le MANS

Le Mans, 72037, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44093, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35033, France

NOT YET RECRUITING

MeSH Terms

Conditions

von Willebrand Diseases; Cardiovascular Diseases; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brigitte PAN PETESCH

CONTACT

02.98.22.36.50; brigitte.pan-petesch@chu-brest.fr

Sara ROBIN

CONTACT

sara.robin@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 17, 2023
• Study Start: December 26, 2021
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three month and ending five years following the publication
• 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.

Locations

FR (6)