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

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ClinicalTrials.gov Identifier: NCT03157154
Recruitment Status : Unknown
Verified August 2017 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : May 17, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Hemophilia Other: Non interventional study

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




Primary Outcome Measures :
  1. Number of bleeding occurrences [ Time Frame: last 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157154


Contacts
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Contact: Marc Trossaërt, Dr 02 40 08 74 68 marc.trossaert@chu-nantes.fr
Contact: Alexandre Desjonquères alexandre.desjonqueres@chu-nantes.fr

Locations
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France
Angers University Hospital Recruiting
Angers, France, 49933
Contact: Philippe BEURRIER, Dr    02 41 35 54 53    phbeurrier@chu-angers.fr   
Principal Investigator: Philippe BEURRIER, Dr         
Brest University Hospital Recruiting
Brest, France, 29609
Contact: Brigitte PAN-PETESCH, Dr    02 98 22 36 50    Brigitte.pan-petesch@chu-brest.fr   
Principal Investigator: Brigitte PAN-PETESCH, Dr         
Le Mans Hospital Recruiting
La Mans, France, 72037
Contact: Fabienne PINEAU-VINCENT, Dr    02 43 43 27 78    fpineauvincent@ch-lemans.fr   
Principal Investigator: Fabienne PINEAU-VINCENT, Dr         
Lyon University Hospital Recruiting
Lyon, France, 69000
Contact: Anne LIENHART, Dr    04 72 11 73 38    Anne.lienhart@chu-lyon.fr   
Principal Investigator: Anne LIENHART, Dr         
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Benoit GUILLET, Dr    02.99.28.24.10    Benoit.guillet@chu-rennes.fr   
Principal Investigator: Benoit GUILLET, Dr         
Tours University Hospital Recruiting
Tours, France, 37170
Contact: Laurent ARDILLON, Dr    06 60 63 23 13    lardillon@hotmail.fr   
Principal Investigator: Laurent ARDILLON, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Marc Trossaërt, Dr Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03157154     History of Changes
Other Study ID Numbers: RC17_0150
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Haemophilia
Atherosclerosis
Atrial fibrillation
Antiplatelets
Anticoagulant
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Anticoagulants