Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

Not Applicable

Recruiting

• Conditions: Hereditary Hemorrhagic Telangiectasia; Rendu Osler Disease
• Interventions: Other: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease

• Registration Number: NCT05641142
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Study Start: 2023-04-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort study	monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease	a single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Biological parameters	3 months after exposure to anticoagulants and/or antiplatelet	Evolution of hemoglobin levels.
Evaluation of Quality of life	week 6, 12, 52 and 104 after patient inclusion	Quality of life assessment via QoL-HHT questionnaire
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

Trial Locations

Locations (18)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU d'Angers; 🇫🇷 Angers, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

CHU de Caen Normandie; 🇫🇷 Caen, France

CHU clermont-ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Dijon; 🇫🇷 Dijon, France

CHRU de Lille; 🇫🇷 Lille, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Nancy; 🇫🇷 Nancy, France

Hospices Civiles de Lyon; 🇫🇷 Lyon, France

Assistance Publique - Hôpitaux de Marseille; 🇫🇷 Marseille, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Nice; 🇫🇷 Nice, France

AP-HP - Hôpital Ténon; 🇫🇷 Paris, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Poitiers; 🇫🇷 Poitiers, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Toulouse; 🇫🇷 Toulouse, France