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

Recruiting

• Conditions: Von Willebrand Diseases

• Registration Number: NCT05773638
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-12-26
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-12-26
• Study Completion: 2026-12-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	12 months	Occurrence of a thromboembolic event validated by an adjudication committee
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.	12 months	Occurrence of a thromboembolic event validated by an adjudication committee

Secondary Outcome Measures

Name	Time	Method
Evaluate the tolerance of these treatments	12 months	Occurrence of clinical haemorrhage
Identify potential risk factors	12 months	identify whether certain risk factors are more prevalent in the population than others
Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions	12 months	Prescription of anticoagulant and/or antiaggregant treatment
Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants	12 months	Revascularisation procedure (endovascular or surgical)
Evaluate the effectiveness of these treatments	12 months	Death from haemorrhage and/or thromboembolic causes.

Trial Locations

Locations (6)

CHU d'Angers; 🇫🇷 Angers, France

CHU de Brest; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

CH le MANS; 🇫🇷 Le Mans, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Rennes; 🇫🇷 Rennes, France