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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Identify potential risk factors [Срок оценки: 12 months]
• Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions [Срок оценки: 12 months]
• Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants [Срок оценки: 12 months]
• Evaluate the tolerance of these treatments [Срок оценки: 12 months]
• Evaluate the effectiveness of these treatments [Срок оценки: 12 months]
• Evaluate the effectiveness of these treatments [Срок оценки: 12 months]
• Evaluate the effectiveness of these treatments [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 6 центров

• CHU d'Angers — Angers
• CHU de Brest — Brest
• CHU de Caen — Caen
• CH le MANS — Le Mans
• CHU de Nantes — Nantes
• CHU de Rennes — Rennes

Публикации

• Granottier A, Trin K, Robin S, Trossaert M, Ardillon L, Tabaux D, Rose J, Beurrier P, Guillet B, Aoubiza I, Pierre-Jean M, Repesse Y, de Moreuil C, Pan-Petesch B. Venous and Arterial Thrombo-Embolic Events in Patients With von Willebrand Disease From Western France: The TWIGO Study. Haemophilia. 2026 May 31. doi: 10.1111/hae.70309. Online ahead of print. PMID 42219913

Идентификаторы

NCT: NCT05773638 · TWIGO ( 29BRC21.0204)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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