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OpenTrials
Completed

NCT Number: NCT03157154

Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

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

Completed

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

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

Primary outcomes

  1. Number of bleeding occurrences

    Time frame: last 12 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: ERHEA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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