NCT05641142

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Apr 2023Apr 2029

First Submitted

Initial submission to the registry

November 18, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

November 18, 2022

Last Update Submit

April 7, 2025

Conditions

Hereditary Hemorrhagic TelangiectasiaRendu Osler Disease

Keywords

epistaxishemorrhageanticoagulant therapyantiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • Number of transfusions and/or intravenous iron

    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.

    3 months after exposure to anticoagulants and/or antiplatelet

Secondary Outcomes (7)

  • Biological parameters

    3 months after exposure to anticoagulants and/or antiplatelet

  • Biological parameters

    3 months after exposure to anticoagulants and/or antiplatelet

  • Bleeding

    3 months after exposure to anticoagulants and/or antiplatelet

  • Anticoagulant and/or antiplatelet treatment

    week 104 after patient inclusion

  • Thrombotic accident

    week 104 after patient inclusion

  • +2 more secondary outcomes

Study Arms (1)

Cohort study

OTHER

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

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

Interventions

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

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

Cohort study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • Patient able to understand and agree to participate in the study
  • Affiliation to a social security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU d'Angers

Angers, France

NOT YET RECRUITING

CHU de Bordeaux

Bordeaux, France

NOT YET RECRUITING

Hôpital Ambroise Paré

Boulogne-Billancourt, France

NOT YET RECRUITING

CHU de Caen Normandie

Caen, France

NOT YET RECRUITING

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

CHU de Dijon

Dijon, France

NOT YET RECRUITING

CHRU de Lille

Lille, France

NOT YET RECRUITING

Hospices Civiles de Lyon

Lyon, France

NOT YET RECRUITING

Assistance Publique - Hôpitaux de Marseille

Marseille, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

CHU de Nancy

Nancy, France

NOT YET RECRUITING

CHU de Nantes

Nantes, France

NOT YET RECRUITING

CHU de Nice

Nice, France

NOT YET RECRUITING

AP-HP - Hôpital Ténon

Paris, France

NOT YET RECRUITING

CHU de Poitiers

Poitiers, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

NOT YET RECRUITING

CHRU de Strasbourg

Strasbourg, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Telangiectasia, Hereditary HemorrhagicEpistaxisHemorrhage

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Vincent GROBOST

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 7, 2022

Study Start

April 7, 2023

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

FR(18)