Von Willebrand DiseasesTWIGONCT05773638
Cardiovascular and Venous Thromboembolism Disease in Patients with Von Willebrand Disease in the French West
An observational study of Von Willebrand Diseases, run by University Hospital, Brest at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Von Willebrand Diseases
- How many people
- 100 participants
- Where
- 6 sitesFrance
- Study dates
- 26 Dec 2021to 26 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- - Expression of opposition
- Acquired von Willebrand syndrome
- Patients under legal protection
- Minor
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sara ROBIN contact
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
CHU d'Angers
Angers, 49933
Philippe BEURRIER
- Recruiting
CHU de Brest
Brest, 29609
Brigitte PAN PETESCH, brigitte.pan-petesch@chu-brest.fr
- Not yet recruiting
CHU de Caen
Caen, 14033
Yohann REPESSE, roux-a@chu-caen.fr
- Not yet recruiting
CH le MANS
Le Mans, 72037
Vincent CUSSAC
- Not yet recruiting
CHU de Nantes
Nantes, 44093
Marc TROSSAERT
- Not yet recruiting
CHU de Rennes
Rennes, 35033
Benoit GUILLET
About this study
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.
Read the 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.
- Conditions
- Von Willebrand Diseases
- Keywords
- von Willebrand disease, venous thromboembolism disease, cardiovascular disease, atrial fibrillation
- Medical subject headings
- von Willebrand Diseases, Cardiovascular Diseases, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (7)
Identify potential risk factors
identify whether certain risk factors are more prevalent in the population than others
Measured: 12 months
Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions
Prescription of anticoagulant and/or antiaggregant treatment
Measured: 12 months
Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants
Revascularisation procedure (endovascular or surgical)
Measured: 12 months
Evaluate the tolerance of these treatments
Occurrence of clinical haemorrhage
Measured: 12 months
Evaluate the effectiveness of these treatments
Occurrence of a cardio-embolic event
Measured: 12 months
Evaluate the effectiveness of these treatments
Occurrence of a thromboembolic recurrence
Measured: 12 months
Evaluate the effectiveness of these treatments
Death from haemorrhage and/or thromboembolic causes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start26 Dec 2021
- Primary completion26 Dec 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Von Willebrand DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773638
- Sponsor's protocol ID
- TWIGO ( 29BRC21.0204)
- Acronym
- TWIGO
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
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.
PubMed 42219913
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Venous Thromboembolism Disease in Patients with Von Willebrand Disease in the French West
- ClinicalTrials.gov ID
- NCT05773638
- Acronym / sponsor ID
- TWIGO / TWIGO ( 29BRC21.0204)
- Conditions
- Von Willebrand Diseases
- Keywords
- von Willebrand disease, venous thromboembolism disease, cardiovascular disease, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Dec 2021 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- - Expression of opposition
- Acquired von Willebrand syndrome
- Patients under legal protection
- Minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 12 months
Occurrence of a thromboembolic event validated by an adjudication committee
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.
Time frame: 12 months
Occurrence of a thromboembolic event validated by an adjudication committee
7 secondary outcomes
Identify potential risk factors
Time frame: 12 months
Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions
Time frame: 12 months
Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants
Time frame: 12 months
Evaluate the tolerance of these treatments
Time frame: 12 months
Evaluate the effectiveness of these treatments
Time frame: 12 months
Evaluate the effectiveness of these treatments
Time frame: 12 months
Evaluate the effectiveness of these treatments
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 42219913Granottier 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Von Willebrand Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara ROBIN contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Diseases, run by University Hospital, Brest at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigitte PAN PETESCH (02.98.22.36.50, brigitte.pan-petesch@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.