Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate in real life, in patients with Hereditary Hemorrhagic Telangiectasia (HHT), the tolerance of the strategy of use of anticoagulant and/or antiplatelet, by comparing a new exposure period (first trimester of treatment) to a period of reference non-exposure (last trimester before start of treatment).

Detailed Description
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Currently there are no recommendations on the use of anticoagulant and/or antiplatelet treatment in patients with Rendu-Osler Disease. The main question this study aims to answer is: • to better determine which anticoagulant and/or antiplatelet therapy are best tolerated or if they are equivalent in Rendu-Osler disease because this type of treatment is often used in urgent and/or vital situations. Participants will have a 2-year follow-up with biological monitoring of ferritin and hemoglobin level and ESS (Epistaxis Severity Score) and QoL-HHT (Quality of Life Hereditary Hemorrhagic Telangiectasia) questionnaires.

Official Title
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Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

Conditions
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Hereditary Hemorrhagic Telangiectasia, Rendu Osler Disease

Intervention / Treatment
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* Other: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Rendu-Osler disease with an indication of antiplatelet and/or anticoagulant introduced for less than 3 months (inclusion period within 3 months of exposure) Age > 18 years old Patient able to understand and agree to participate in the study Affiliation to a social security system Exclusion Criteria: Patient with an indication of antiplatelet and/or anticoagulant but for whom treatment has not been introduced or introduced for more than 3 months Refusal to participate Pregnant woman or who are breast feeding Patients under maintenance of justice, wardship or legal guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort study<br>a single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study | Other: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease<br>* Monitoring: hemoglobin and ferritin levels transfusion or intravenous iron hospitalization for bleeding or thrombose digestive bleeding and/or another haemorrhagic accident severity of epistaxis quality of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of transfusions and/or intravenous iron | Number of transfusions and/or intravenous iron before (3 months) and within 3 months after exposure to anticoagulants and/or antiplatelet in patients with Rendu-Osler disease. | 3 months after exposure to anticoagulants and/or antiplatelet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological parameters | Evolution of ferritin levels. | 3 months after exposure to anticoagulants and/or antiplatelet | 
| Biological parameters | Evolution of hemoglobin levels. | 3 months after exposure to anticoagulants and/or antiplatelet | 
| Bleeding | Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage. | 3 months after exposure to anticoagulants and/or antiplatelet | 
| Anticoagulant and/or antiplatelet treatment | Frequency of continuation and/or modification and/or cessation of treatment if indication maintained. | week 104 after patient inclusion | 
| Thrombotic accident | Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death | week 104 after patient inclusion | 
| Epistaxis | Evolution of epistaxis severity via ESS score | week 12, 52 and 104 after patient inclusion | 
| Evaluation of Quality of life | Quality of life assessment via QoL-HHT questionnaire | week 6, 12, 52 and 104 after patient inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulant therapy, epistaxis, hemorrhage, antiplatelet therapy