Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

NCT ID: NCT05641142

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-07

Study Completion Date

2029-04-30

Brief Summary

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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

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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.

Conditions

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Hereditary Hemorrhagic Telangiectasia Rendu Osler Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

cohort study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort study

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

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent GROBOST

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU d'Angers

Angers, , France

Site Status NOT_YET_RECRUITING

CHU de Bordeaux

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Site Status NOT_YET_RECRUITING

CHU de Caen Normandie

Caen, , France

Site Status NOT_YET_RECRUITING

CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

CHU de Dijon

Dijon, , France

Site Status NOT_YET_RECRUITING

CHRU de Lille

Lille, , France

Site Status NOT_YET_RECRUITING

Hospices Civiles de Lyon

Lyon, , France

Site Status NOT_YET_RECRUITING

Assistance Publique - Hôpitaux de Marseille

Marseille, , France

Site Status NOT_YET_RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status NOT_YET_RECRUITING

CHU de Nancy

Nancy, , France

Site Status NOT_YET_RECRUITING

CHU de Nantes

Nantes, , France

Site Status NOT_YET_RECRUITING

CHU de Nice

Nice, , France

Site Status NOT_YET_RECRUITING

AP-HP - Hôpital Ténon

Paris, , France

Site Status NOT_YET_RECRUITING

CHU de Poitiers

Poitiers, , France

Site Status NOT_YET_RECRUITING

CHU de Rennes

Rennes, , France

Site Status NOT_YET_RECRUITING

CHRU de Strasbourg

Strasbourg, , France

Site Status NOT_YET_RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

334.73.754.963

Facility Contacts

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Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Sandra Blivet

Role: backup

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Lise Laclautre

Role: primary

Other Identifiers

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2022-A00754-39

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2022 GROBOST

Identifier Type: -

Identifier Source: org_study_id

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