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

HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound on Disease Management and Treatment Decision-making in Moderate and Severe Haemophilia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03237273

Enrollment

200

Registered

2017-08-02

Start date

2015-12-31

Completion date

2017-12-31

Last updated

2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate and Severe Haemophilia

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

Interventions

OTHERHEAD-US scoring system

HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
% 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

Contacts

Primary ContactCollette Pigden, MSc

collette.pigden@gstt.nhs.uk020 7188 7188

Backup ContactPaschos, MSc

christos.paschos@gstt.nhs.uk020 7188 2775

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026