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

December 6, 2023 updated by: University Hospital, Clermont-Ferrand
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).

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Not yet recruiting
        • CHU d'Angers
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Christian LAVIGNE
      • Bordeaux, France
        • Not yet recruiting
        • CHU de Bordeaux
        • Principal Investigator:
          • Pierre DUFFAU
        • Contact:
          • Lise Laclautre
      • Boulogne-Billancourt, France
        • Not yet recruiting
        • Hopital Ambroise Pare
        • Contact:
          • Sandra Blivet
        • Contact:
          • Lise Laclautre
      • Caen, France
        • Not yet recruiting
        • Chu de Caen Normandie
        • Principal Investigator:
          • Laurent Chaussavoine
        • Contact:
          • Lise Laclautre
      • Clermont-Ferrand, France
        • Recruiting
        • Chu Clermont-Ferrand
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Vincent GROBOST
      • Dijon, France
        • Not yet recruiting
        • CHU de Dijon
        • Principal Investigator:
          • Hélène GREIGERT
        • Contact:
          • Lise Laclautre
      • Lille, France
        • Not yet recruiting
        • CHRU de Lille
        • Principal Investigator:
          • Hélène Maillard
        • Contact:
          • Lise Laclautre
      • Lyon, France
        • Not yet recruiting
        • Hospices Civiles de Lyon
        • Principal Investigator:
          • Sophie Dupuis-Girod
        • Contact:
          • Lise Laclautre
      • Marseille, France
        • Not yet recruiting
        • Assistance Publique - Hopitaux de Marseille
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Baptiste André
      • Montpellier, France
        • Not yet recruiting
        • CHU de Montpellier
        • Principal Investigator:
          • Sophie Rivière
        • Contact:
          • Lise Laclautre
      • Nancy, France
        • Not yet recruiting
        • Chu de Nancy
        • Principal Investigator:
          • Shirine MOHAMED
        • Contact:
          • Lise Laclautre
      • Nantes, France
        • Not yet recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Giovanni Gautier
        • Contact:
          • Lise Laclautre
      • Nice, France
        • Not yet recruiting
        • CHU de Nice
        • Principal Investigator:
          • Johana Pradelli
        • Contact:
          • Lise Laclautre
      • Paris, France
        • Not yet recruiting
        • AP-HP - Hopital Tenon
        • Principal Investigator:
          • Antoine PARROT
        • Contact:
          • Lise Laclautre
      • Poitiers, France
        • Not yet recruiting
        • CHU de Poitiers
        • Principal Investigator:
          • Xavier Le Guillou Horn
        • Contact:
          • Lise Laclautre
      • Rennes, France
        • Not yet recruiting
        • CHU de Rennes
        • Principal Investigator:
          • Mallorie KERJOUAN
        • Contact:
          • Lise Laclautre
      • Strasbourg, France
        • Not yet recruiting
        • CHRU de Strasbourg
        • Principal Investigator:
          • Murielle RONDEAU-LUTZ
        • Contact:
          • Lise Laclautre
      • Toulouse, France
        • Not yet recruiting
        • CHU de Toulouse
        • Contact:
          • Lise Laclautre
        • Principal Investigator:
          • Laurent Alric

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort study
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of transfusions and/or intravenous iron
Time Frame: 3 months after exposure to anticoagulants and/or antiplatelet
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological parameters
Time Frame: 3 months after exposure to anticoagulants and/or antiplatelet
Evolution of ferritin levels.
3 months after exposure to anticoagulants and/or antiplatelet
Biological parameters
Time Frame: 3 months after exposure to anticoagulants and/or antiplatelet
Evolution of hemoglobin levels.
3 months after exposure to anticoagulants and/or antiplatelet
Bleeding
Time Frame: 3 months after exposure to anticoagulants and/or antiplatelet
Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage.
3 months after exposure to anticoagulants and/or antiplatelet
Anticoagulant and/or antiplatelet treatment
Time Frame: week 104 after patient inclusion
Frequency of continuation and/or modification and/or cessation of treatment if indication maintained.
week 104 after patient inclusion
Thrombotic accident
Time Frame: week 104 after patient inclusion
Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death
week 104 after patient inclusion
Epistaxis
Time Frame: week 12, 52 and 104 after patient inclusion
Evolution of epistaxis severity via ESS score
week 12, 52 and 104 after patient inclusion
Evaluation of Quality of life
Time Frame: week 6, 12, 52 and 104 after patient inclusion
Quality of life assessment via QoL-HHT questionnaire
week 6, 12, 52 and 104 after patient inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Vincent GROBOST, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2022 GROBOST
  • 2022-A00754-39 (Other Identifier: 2022-A00754-39)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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