Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia (PROPLACO-Tel)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Hereditary Hemorrhagic Telangiectasia; Rendu Osler Disease

Treatments: Other: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease

Study type: Interventional

Funder types: Other

Identifiers

NCT05641142

2022-A00754-39 (Other Identifier)

RBHP 2022 GROBOST

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Cohort study

Other group

Description:

a single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study

Treatment:

Other: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease