Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-27

Study Completion Date

2017-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

NCT05641142

Hereditary Hemorrhagic Telangiectasia Rendu Osler Disease

RECRUITING NA

Early Versus Late Resumption of Anticoagulation in Patients With Both High Thrombosis Risk and Major HEmoRrhage

NCT02091479

Major hæmorrhage

TERMINATED PHASE3

Comparative Study of the Hemorrhagic Risk in Patients Over 75 Years of Age Taking Enoxaparin

NCT05150314

Venous Thromboembolic Disease

UNKNOWN

Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants

NCT02185027

Venous Thromboembolism Atrial Fibrillation

COMPLETED

Bleeding Events After Triple Antithrombotic Therapy Initiation.

NCT03203980

Bleeding

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemophilia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

First group

Haemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis

Non interventional study

Intervention Type OTHER

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).

Non interventional study

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non interventional study

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No