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Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03157154
Acronym
ERHEA
Enrollment
259
Registered
2017-05-17
Start date
2017-06-27
Completion date
2017-07-30
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia

Keywords

Haemophilia, Atherosclerosis, Atrial fibrillation, Antiplatelets, Anticoagulant

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

Interventions

OTHERNon interventional study

A query form to all concerned patients by each investigating centre will be send

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Number of bleeding occurrenceslast 12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026