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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

Tracking Information
First Submitted Date May 16, 2017
First Posted Date May 17, 2017
Last Update Posted Date August 11, 2017
Actual Study Start Date June 27, 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2017)
Number of bleeding occurrences [ Time Frame: last 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03157154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
Official Title Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Hemophilia
Intervention Other: Non interventional study
A query form to all concerned patients by each investigating centre will be send
Study Groups/Cohorts
  • First group
    Haemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis
    Intervention: Other: Non interventional study
  • 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).
    Intervention: Other: Non interventional study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 16, 2017)
140
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03157154
Other Study ID Numbers RC17_0150
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Marc Trossaërt, Dr Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date August 2017