Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination

Swedish Orphan Biovitrum88 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Hemophilia A

Interventions

Ultrasound, Haemophilia Joint Health ScorePROCEDURE

Systematic joint examinations of ankles, knees and elbows

Eligibility

Sex: ALLMin age: 6 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (20)

Swedish Orphan Biovitrum Research site

Angers, France

Swedish Orphan Biovitrum Research site

Bordeaux, France

Outcomes

Primary Outcomes

Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US

Yes/No

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.