MedTrace Logo

Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

NCT03157154 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 259

Last updated 2020-01-23

No results posted yet for this study

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

Conditions

Interventions

OTHER

Non interventional study

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Marc Trossaërt, Dr · Nantes University Hospital

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2017-07-30
Completion
2017-07-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03157154 on ClinicalTrials.gov