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

Primary Purpose

Hereditary Hemorrhagic Telangiectasia, Rendu Osler Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hereditary Hemorrhagic Telangiectasia focused on measuring epistaxis, hemorrhage, anticoagulant therapy, antiplatelet therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU d'Angers
  • CHU de Bordeaux
  • Hôpital Ambroise Paré
  • CHU de Caen Normandie
  • CHU clermont-ferrandRecruiting
  • CHU de Dijon
  • CHRU de Lille
  • Hospices Civiles de Lyon
  • CHU de Montpellier
  • CHU de Nancy
  • CHU de Nantes
  • CHU de Nice
  • AP-HP - Hôpital Ténon
  • CHU de Poitiers
  • CHU de Rennes
  • CHRU de Strasbourg
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort study

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Biological parameters
Evolution of ferritin levels.
Biological parameters
Evolution of hemoglobin levels.
Bleeding
Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage.
Anticoagulant and/or antiplatelet treatment
Frequency of continuation and/or modification and/or cessation of treatment if indication maintained.
Thrombotic accident
Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death
Epistaxis
Evolution of epistaxis severity via ESS score
Evaluation of Quality of life
Quality of life assessment via QoL-HHT questionnaire

Full Information

First Posted
November 18, 2022
Last Updated
July 7, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05641142
Brief Title
Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
Acronym
PROPLACO-Tel
Official Title
Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Hemorrhagic Telangiectasia, Rendu Osler Disease
Keywords
epistaxis, hemorrhage, anticoagulant therapy, antiplatelet therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort study
Arm Type
Other
Arm Description
a single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study
Intervention Type
Other
Intervention Name(s)
monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease
Intervention Description
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 Measure Information:
Title
Number of transfusions and/or intravenous iron
Description
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.
Time Frame
3 months after exposure to anticoagulants and/or antiplatelet
Secondary Outcome Measure Information:
Title
Biological parameters
Description
Evolution of ferritin levels.
Time Frame
3 months after exposure to anticoagulants and/or antiplatelet
Title
Biological parameters
Description
Evolution of hemoglobin levels.
Time Frame
3 months after exposure to anticoagulants and/or antiplatelet
Title
Bleeding
Description
Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage.
Time Frame
3 months after exposure to anticoagulants and/or antiplatelet
Title
Anticoagulant and/or antiplatelet treatment
Description
Frequency of continuation and/or modification and/or cessation of treatment if indication maintained.
Time Frame
week 104 after patient inclusion
Title
Thrombotic accident
Description
Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death
Time Frame
week 104 after patient inclusion
Title
Epistaxis
Description
Evolution of epistaxis severity via ESS score
Time Frame
week 12, 52 and 104 after patient inclusion
Title
Evaluation of Quality of life
Description
Quality of life assessment via QoL-HHT questionnaire
Time Frame
week 6, 12, 52 and 104 after patient inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent GROBOST
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Christian LAVIGNE
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Pierre DUFFAU
Facility Name
Hôpital Ambroise Paré
City
Boulogne-Billancourt
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Sandra Blivet
Facility Name
CHU de Caen Normandie
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Laurent Chaussavoine
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Vincent GROBOST
Facility Name
CHU de Dijon
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Hélène GREIGERT
Facility Name
CHRU de Lille
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Hélène Maillard
Facility Name
Hospices Civiles de Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Sophie Dupuis-Girod
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Sophie Rivière
Facility Name
CHU de Nancy
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Shirine MOHAMED
Facility Name
CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Giovanni Gautier
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Johana PRADELLI
Facility Name
AP-HP - Hôpital Ténon
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Antoine PARROT
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Xavier Le Guillou Horn
Facility Name
CHU de Rennes
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Mallorie KERJOUAN
Facility Name
CHRU de Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Murielle RONDEAU-LUTZ
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Laurent Alric

12. IPD Sharing Statement

Learn more about this trial

Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

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