Cardiovascular and Venous Thromboembolism Disease in Patients With Von Willebrand Disease in the French West (TWIGO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Von Willebrand Diseases

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers
  • Brest, France, 29609
    • CHU de Brest
  • Caen, France, 14033
    • CHU de Caen
  • Le Mans, France, 72037
    • CH Le Mans
  • Nantes, France, 44093
    • CHU de Nantes
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2021
• Primary Completion (Anticipated): December 26, 2023
• Study Completion (Anticipated): December 26, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; cardiovascular disease; venous thromboembolism disease; von Willebrand disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Embolism and Thrombosis; Blood Coagulation Disorders; Blood Platelet Disorders; Thromboembolism; Venous Thromboembolism; Von Willebrand Diseases
• Other Study ID Numbers: TWIGO ( 29BRC21.0204)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three month and ending five years following the publication
• 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No