Hereditary Hemorrhagic TelangiectasiaPROPLACO-TelNCT05641142
Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
A study testing monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease in people with Hereditary Hemorrhagic Telangiectasia and Rendu Osler Disease, run by University Hospital, Clermont-Ferrand at 18 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Hemorrhagic Telangiectasia, Rendu Osler Disease
- What is being tested?
- monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesFrance
- Study dates
- 7 Apr 2023to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
France18 sites, 18 recruiting
- Recruiting
CHU d'Angers
Angers
Lise Laclautre
Christian LAVIGNE
- Recruiting
CHU de Bordeaux
Bordeaux
Lise Laclautre
Pierre DUFFAU
- Not yet recruiting
Hôpital Ambroise Paré
Boulogne-Billancourt
Lise Laclautre
Sandra Blivet
- Recruiting
CHU de Caen Normandie
Caen
Lise Laclautre
Laurent Chaussavoine
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Vincent GROBOST
- Recruiting
CHU de Dijon
Dijon
Lise Laclautre
Hélène GREIGERT
- Not yet recruiting
CHRU de Lille
Lille
Lise Laclautre
Hélène Maillard
- Recruiting
Hospices Civiles de Lyon
Lyon
Lise Laclautre
Sophie Dupuis-Girod
- Not yet recruiting
Assistance Publique - Hôpitaux de Marseille
Marseille
Lise Laclautre
Baptiste André
- Recruiting
CHU de Montpellier
Montpellier
Lise Laclautre
Sophie Rivière
- Recruiting
CHU de Nancy
Nancy
Lise Laclautre
Shirine MOHAMED
- Recruiting
CHU de Nantes
Nantes
Lise Laclautre
Giovanni Gautier
- Recruiting
CHU de Nice
Nice
Lise Laclautre
Johana PRADELLI
- Recruiting
AP-HP - Hôpital Ténon
Paris
Lise Laclautre
Michel DJIBRE
- Not yet recruiting
CHU de Poitiers
Poitiers
Lise Laclautre
Xavier Le Guillou Horn
- Recruiting
CHU de Rennes
Rennes
Lise Laclautre
Mallorie KERJOUAN
- Recruiting
CHRU de Strasbourg
Strasbourg
Lise Laclautre
Murielle RONDEAU-LUTZ
- Not yet recruiting
CHU de Toulouse
Toulouse
Lise Laclautre
Laurent Alric
About this study
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).
Read the 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.
- Being tested
- monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease
- Keywords
- epistaxis, hemorrhage, anticoagulant therapy, antiplatelet therapy
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Epistaxis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort study | Other | a single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study Receives: Other: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after exposure to anticoagulants and/or antiplatelet
Secondary outcomes (7)
Biological parameters
Evolution of ferritin levels.
Measured: 3 months after exposure to anticoagulants and/or antiplatelet
Biological parameters
Evolution of hemoglobin levels.
Measured: 3 months after exposure to anticoagulants and/or antiplatelet
Bleeding
Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage.
Measured: 3 months after exposure to anticoagulants and/or antiplatelet
Anticoagulant and/or antiplatelet treatment
Frequency of continuation and/or modification and/or cessation of treatment if indication maintained.
Measured: week 104 after patient inclusion
Thrombotic accident
Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death
Measured: week 104 after patient inclusion
Epistaxis
Evolution of epistaxis severity via ESS score
Measured: week 12, 52 and 104 after patient inclusion
Evaluation of Quality of life
Quality of life assessment via QoL-HHT questionnaire
Measured: week 6, 12, 52 and 104 after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start7 Apr 2023
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Hemorrhagic TelangiectasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GROBOST, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641142
- Sponsor's protocol ID
- RBHP 2022 GROBOST
- Other IDs
- 2022-A00754-39
- Acronym
- PROPLACO-Tel
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
- ClinicalTrials.gov ID
- NCT05641142
- Acronym / sponsor ID
- PROPLACO-Tel / RBHP 2022 GROBOST
- Keywords
- epistaxis, hemorrhage, anticoagulant therapy, antiplatelet therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| Cohort study | Other | Other: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering diseasea single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering diseaseMonitoring: * 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 | Other | Cohort study |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent GROBOST principal investigator
University Hospital, Clermont-Ferrand
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease in people with Hereditary Hemorrhagic Telangiectasia and Rendu Osler Disease, run by University Hospital, Clermont-Ferrand at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of transfusions and/or intravenous iron (time frame: 3 months after exposure to anticoagulants and/or antiplatelet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.