Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

Hereditary Hemorrhagic Telangiectasia Clinical Trial

— PROPLACO-Tel  

Official title:

Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641142
• Other study ID #: RBHP 2022 GROBOST
• Secondary ID: 2022-A00754-39
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: January 2027

Study information

• Verified date: April 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 before start of treatment).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Hemorrhagic Telangiectasia
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

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

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Bordeaux	Bordeaux
France	Hôpital Ambroise Paré	Boulogne-Billancourt
France	CHU de Caen Normandie	Caen
France	CHU clermont-ferrand	Clermont-Ferrand
France	CHU de Dijon	Dijon
France	CHRU de Lille	Lille
France	Hospices Civiles de Lyon	Lyon
France	Assistance Publique - Hôpitaux de Marseille	Marseille
France	CHU de Montpellier	Montpellier
France	CHU de Nancy	Nancy
France	CHU de Nantes	Nantes
France	CHU de Nice	Nice
France	AP-HP - Hôpital Ténon	Paris
France	CHU de Poitiers	Poitiers
France	CHU de Rennes	Rennes
France	CHRU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biological parameters	Evolution of ferritin levels.	3 months after exposure to anticoagulants and/or antiplatelet
Secondary	Biological parameters	Evolution of hemoglobin levels.	3 months after exposure to anticoagulants and/or antiplatelet
Secondary	Bleeding	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
Secondary	Anticoagulant and/or antiplatelet treatment	Frequency of continuation and/or modification and/or cessation of treatment if indication maintained.	week 104 after patient inclusion
Secondary	Thrombotic accident	Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death	week 104 after patient inclusion
Secondary	Epistaxis	Evolution of epistaxis severity via ESS score	week 12, 52 and 104 after patient inclusion
Secondary	Evaluation of Quality of life	Quality of life assessment via QoL-HHT questionnaire	week 6, 12, 52 and 104 after patient inclusion