Clinical trial NCT03157154: Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
Official title: Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Keywords: Haemophilia
Atherosclerosis
Atrial fibrillation
Antiplatelets
Anticoagulant
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 259
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haemophilia patients (man, all severity)

Age above 50 years, followed during the last 5 years in one of the study centre

Brief summary: Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.

The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.

Secondary endpoint consist in:

* Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
* Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
* Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
* Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
* Estimate the embolic risk of haemophilia patients with atrial fibrillation

Population description:

Haemophilia patients (man, all severity)

Age above 50 years, followed during the last 5 years in one of the study centre


Eligibility criteria: Inclusion Criteria:

* Male
* Age above 50 years
* Hemophilia A or B carriers
* Followed within the 5 last years in one of the research center

Exclusion Criteria:

* Jurisdictional prevention procedures
* Other medical condition that might interfere with the bleeding risk (Willebrand's disease, Other coagulation factor deficiencies, haematological malignancies, ...)
* Other drugs that might interfere with the bleeding risk (Serotonin reuptake inhibitors)
* Patient refusal

Primary outcomes:
measure: Number of bleeding occurrences
timeFrame: last 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: La Mans
country: France
facility: Le Mans Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Marc Trossaërt, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desjonqueres A, Guillet B, Beurrier P, Pan-Petesch B, Ardillon L, Pineau-Vincent F, Sigaud M, Fouassier M, Ternisien C, Gillet B, Bene MC, Horvais V, Lienhart A, Trossaert M. Bleeding risk for patients with haemophilia under antithrombotic therapy. Results of the French multicentric study ERHEA. Br J Haematol. 2019 May;185(4):764-767. doi: 10.1111/bjh.15606. Epub 2018 Oct 18. No abstract available.