Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies (ERHEA)

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 Overview

• Status: Completed
• Conditions: Hemophilia
• Intervention / Treatment: Other: Non interventional study

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Angers University hospital
  • Brest, France, 29609
    • Brest University Hospital
  • La Mans, France, 72037
    • Le Mans Hospital
  • Lyon, France, 69000
    • Lyon University Hospital
  • Rennes, France, 35033
    • Rennes University Hospital
  • Tours, France, 37170
    • Tours University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First group; Haemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis	Other: Non interventional study; A query form to all concerned patients by each investigating centre will be send
Control group; 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).	Other: Non interventional study; A query form to all concerned patients by each investigating centre will be send

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of bleeding occurrences	last 12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Atherosclerosis; Haemophilia; Anticoagulant; Antiplatelets
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: RC17_0150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No