Hemophilia A
Conditions
Keywords
joint health
Brief summary
This low interventional study aims to describe if and how the haemophilia treatment management decisions are impacted by a systematic joint examination (ultrasound, functional, physical) in patients with haemophilia A in France.
Detailed description
The study will assess the behavior of the physicians with regards to haemophilia management decisions, and if systematic joint examination have an impact on their decisions. The main objective is to evaluate if the use of HEAD-US and Haemophilia Joint Health Score (HJHS) have an impact on these decisions. The study is classified as a low-interventional study due to mandated systematically assessment (HEAD-US, HJHS) on patients which may not be part of routine clinical practice.
Interventions
Systematic joint examinations of ankles, knees and elbows
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 6-40 years * Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII) * At least one joint bleeding episode prior to inclusion * Signed informed consent
Exclusion criteria
* Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product, within three months prior to inclusion in the study * Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit \[BU\]/mL) at the latest available inhibitor test * Joint surgery over the past year prior to inclusion in one of the following joints; left knee, right knee, left elbow, right elbow, left ankle and right ankle * More than one joint replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US | 12 months | Yes/No |
Countries
France