Brief Title
Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
Official Title
Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
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
Study Type
Observational
Primary Outcome
Number of bleeding occurrences
Condition
Hemophilia
Intervention
Non interventional study
Study Arms / Comparison Groups
First group
Description: Haemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
259
Start Date
June 27, 2017
Completion Date
July 30, 2017
Primary Completion Date
July 30, 2017
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
Gender
Male
Ages
50 Years - N/A
Contacts
Marc Trossaërt, Dr, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03157154
Organization ID
RC17_0150
Responsible Party
Sponsor
Study Sponsor
Nantes University Hospital
Study Sponsor
Marc Trossaërt, Dr, Principal Investigator, Nantes University Hospital
Verification Date
January 2020