HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound

Not Applicable

• Conditions: Moderate and Severe Haemophilia
• Interventions: Other: HEAD-US scoring system

• Registration Number: NCT03237273
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

Ultrasound represents a promising technique for the assessment of joint health in persons with haemophilia (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. Further work is needed to assess the real-world impact of ultrasound on disease management and treatment decision-making.

Detailed Description

Patients are seen routinely in clinic by specialist haemophilia physiotherapists who assess the patients using the Haemophilia Joint Health Score tool (HJHS). Trial participants will be seen during their routine clinic visits and will be seen by a clinician and the physiotherapist who will carry out the routine assessment along with the HEAD-US scan.

Patients will be seen a maximum of 4 times throughout the year from registration of the first patient, according to their visit schedule, but will only be scanned at the first visit.

Results will be analysed to determine if the treatment decision-making is influenced by the results of the scan

Study Timeline

• Study Start: 2015-12
• Status Verified: 2017-07
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Study First Posted: 2017-08-02
• Last Update Posted: 2017-08-02
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Moderate (FVIII/FIX:C 1-5%) and severe (FVIII/FIX: C <1%) patients with haemophilia A or B aged ≥ 6 years
• On demand or prophylaxis treatment regimen

Exclusion Criteria

• Joints with a previous history of surgery
• Joints with damage as a result of causes other than haemophilia-related bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	HEAD-US scoring system	All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist

Primary Outcome Measures

Name	Time	Method
Any change in treatment	12 months	Any change in treatment including, management of a bleed and/or change in routine treatment protocol (including changes to prophylaxis regimen, or decision to start/stop prophylaxis regimen) as a result of the ultrasound findings

Secondary Outcome Measures

Name	Time	Method
% joints with normal HJHS and abnormal HEAD-US score	12 months	% joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately
% joints with abnormal HJHS and normal HEAD-US score	12 months	% joints with abnormal HJHS and normal HEAD-US score