A Study to Investigate if the Use of a Systematic Joint Examination (Ultrasound/Functional/Physical) Has an Impact on the Physician's Haemophilia Treatment Management Decision in Patients With Haemophilia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 20
- 主要终点
- Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
时间窗: 12 months
Yes/No
次要结局
未报告次要终点