HEAD-US SCORING SYSTEM-Real life experience study
Research type
Research Study
Full title
Head-Us Scoring System: Assessment of the real-world impact of ultrasound on disease management and treatment decision-making in moderate and severe haemophilia
IRAS ID
191576
Contact name
Gerard Dolan
Contact email
Sponsor organisation
Guy's and St. Thomas' NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Ultrasound represents a promising technique for the assessment of joint health in persons with heamophilia (PWH) by non-imaging specialists. The haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating joint ultrasound in the routine assessment of PWH through the use of a simplified scoring system. The inter-operator reliability of the technique among European haemophilia treaters has been validated and described elsewhere.
This study aims to assess the real-world impact of ultrasound on disease management and treatment decision making in children (≥6 years of age), adolescents and adults with haemophilia and to understand the true extent of ultrasound as a diagnostic tool compared with thorough physical examination.
The study is designed as a cross-sectional, multicentre study to be carried out across Europe. 12-month retrospective data will be collected and patients will be assessed on clinical visits for up to 12 months from the start of the study (at 4, 8 and 12 months).
Eligible participants for this study will be patients undergoing joint examination with ultrasound using the HEAD-US protocol as part of their routine clinical assessment. They will have a confirmed diagnosis of moderate (FVIII/FIX:C 1–5%) or severe (FVIII/FIX:C <1%) haemophilia A or haemophilia B and be aged ≥6 years. They will be either on a prophylactic or an on-demand treatment regime.
Joints with a previous history of surgery and joints with damage as a result of causes other than haemophilia-related bleeding will be excluded from the study.
A minimum of 200 participants will be recruited to the study with each of the centres enrolling 30-40 participants.
The primary outcome of the study will be any change in treatment including management of a bleed and/or change in routine treatment protocol as a result of ultrasound findings.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0187
Date of REC Opinion
20 May 2016
REC opinion
Further Information Favourable Opinion