An interventional study of monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease in Hereditary Hemorrhagic Telangiectasia and Rendu Osler Disease, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
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).
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:
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.
106 studies on the registry are indexed under Telangiectasia, Hereditary Hemorrhagic; 24 are open to participants now.
This study's planned enrollment of 100 is above the median of 33 across 61 interventional studies indexed under Telangiectasia, Hereditary Hemorrhagic.
Browse Telangiectasia, Hereditary Hemorrhagic studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
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
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
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.
Time frame: 3 months after exposure to anticoagulants and/or antiplatelet
Biological parameters
Evolution of ferritin levels.
Time frame: 3 months after exposure to anticoagulants and/or antiplatelet
Biological parameters
Evolution of hemoglobin levels.
Time frame: 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.
Time frame: 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.
Time frame: week 104 after patient inclusion
Thrombotic accident
Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death
Time frame: week 104 after patient inclusion
Epistaxis
Evolution of epistaxis severity via ESS score
Time frame: week 12, 52 and 104 after patient inclusion
Evaluation of Quality of life
Quality of life assessment via QoL-HHT questionnaire
Time frame: week 6, 12, 52 and 104 after patient inclusion
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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