Hereditary Hemorrhagic Telangiectasia, Rendu Osler Disease
Conditions
Keywords
epistaxis, hemorrhage, anticoagulant therapy, antiplatelet therapy
Brief summary
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
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.
Interventions
OTHERmonitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease
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
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of transfusions and/or intravenous iron | 3 months after exposure to anticoagulants and/or antiplatelet | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological parameters | 3 months after exposure to anticoagulants and/or antiplatelet | Evolution of ferritin levels. |
| Bleeding | 3 months after exposure to anticoagulants and/or antiplatelet | Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage. |
| Anticoagulant and/or antiplatelet treatment | week 104 after patient inclusion | Frequency of continuation and/or modification and/or cessation of treatment if indication maintained. |
| Thrombotic accident | week 104 after patient inclusion | Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death |
| Epistaxis | week 12, 52 and 104 after patient inclusion | Evolution of epistaxis severity via ESS score |
| Evaluation of Quality of life | week 6, 12, 52 and 104 after patient inclusion | Quality of life assessment via QoL-HHT questionnaire |
Countries
France
Contacts
CONTACTLise Laclautre
PRINCIPAL_INVESTIGATORVincent GROBOST
University Hospital, Clermont-Ferrand
Outcome results
None listed