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Recruiting NCT05641142

Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

No phase Interventional Hereditary Hemorrhagic Telangiectasia Rendu Osler Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease.
Who it may be relevant to
Registry conditions: Hereditary Hemorrhagic Telangiectasia, Rendu Osler Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

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.

Interventions

  • Other 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

Primary outcome measures

  • Number of transfusions and/or intravenous iron [Time frame: 3 months after exposure to anticoagulants and/or antiplatelet]
Secondary outcome measures (7)
  • Biological parameters [Time frame: 3 months after exposure to anticoagulants and/or antiplatelet]
  • Biological parameters [Time frame: 3 months after exposure to anticoagulants and/or antiplatelet]
  • Bleeding [Time frame: 3 months after exposure to anticoagulants and/or antiplatelet]
  • Anticoagulant and/or antiplatelet treatment [Time frame: week 104 after patient inclusion]
  • Thrombotic accident [Time frame: week 104 after patient inclusion]
  • Epistaxis [Time frame: week 12, 52 and 104 after patient inclusion]
  • Evaluation of Quality of life [Time frame: week 6, 12, 52 and 104 after patient inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 18 centers
  • 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
  • … and 10 more centers

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗