Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Hemophilia Clinical Trial

— ERHEA  

Official title:

Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157154
• Other study ID #: RC17_0150
• Status: Completed
• Start date: June 27, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: January 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Other:
• Non interventional study
A query form to all concerned patients by each investigating centre will be send

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Brest University Hospital	Brest
France	Le Mans Hospital	La Mans
France	Lyon University Hospital	Lyon
France	Rennes University Hospital	Rennes
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding occurrences		last 12 months