Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease
Other interventionMonitoring: * 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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Cohort studyOther 1 intervention
Trial outcomes
Primary outcomes
1
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 antiplateletSecondary outcomes
1
Biological parameters
Evolution of ferritin levels.
Time frame
3 months after exposure to anticoagulants and/or antiplatelet2
Biological parameters
Evolution of hemoglobin levels.
Time frame
3 months after exposure to anticoagulants and/or antiplatelet3
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 antiplatelet4
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 inclusionSponsors and contacts
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Source ClinicalTrials.gov