Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Number of transfusions and/or intravenous iron [Срок оценки: 3 months after exposure to anticoagulants and/or antiplatelet]

Вторичные конечные точки (7)

• Biological parameters [Срок оценки: 3 months after exposure to anticoagulants and/or antiplatelet]
• Biological parameters [Срок оценки: 3 months after exposure to anticoagulants and/or antiplatelet]
• Bleeding [Срок оценки: 3 months after exposure to anticoagulants and/or antiplatelet]
• Anticoagulant and/or antiplatelet treatment [Срок оценки: week 104 after patient inclusion]
• Thrombotic accident [Срок оценки: week 104 after patient inclusion]
• Epistaxis [Срок оценки: week 12, 52 and 104 after patient inclusion]
• Evaluation of Quality of life [Срок оценки: week 6, 12, 52 and 104 after patient inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 18 центров

• CHU d'Angers — Angers
• CHU de Bordeaux — Bordeaux
• Hôpital Ambroise Paré — Boulogne-Billancourt
• CHU de Caen Normandie — Caen
• CHU clermont-ferrand — Clermont-Ferrand
• CHU de Dijon — Dijon
• CHRU de Lille — Lille
• Hospices Civiles de Lyon — Lyon
• … и ещё 10 центров

Идентификаторы

NCT: NCT05641142 · RBHP 2022 GROBOST · 2022-A00754-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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