Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Completed

• Conditions: Hemophilia
• Interventions: Other: Non interventional study

• Registration Number: NCT03157154
• Lead Sponsor: Nantes University Hospital

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-06-27
• Primary Completion: 2017-07-30
• Study Completion: 2017-07-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 259

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Non interventional study	Haemophilia patient without such history or treatment matched on age and disease status (haemophilia A or B and the severity of the disease : severe, mild, minor).
First group	Non interventional study	Haemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis

Primary Outcome Measures

Name	Time	Method
Number of bleeding occurrences	last 12 months

Trial Locations

Locations (6)

Le Mans Hospital; 🇫🇷 La Mans, France

Angers University Hospital; 🇫🇷 Angers, France

Brest University Hospital; 🇫🇷 Brest, France

Lyon University Hospital; 🇫🇷 Lyon, France

Rennes University Hospital; 🇫🇷 Rennes, France

Tours University Hospital; 🇫🇷 Tours, France