Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

University Hospital, Clermont-Ferrand100 enrolled

Overview

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: • 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Hereditary Hemorrhagic Telangiectasia Rendu Osler Disease

Interventions

monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering diseaseOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

CHU d'Angers

Angers, France

NOT_YET_RECRUITING

CHU de Bordeaux

Bordeaux, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Lise Laclautre

CONTACT

334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Data from ClinicalTrials.gov

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