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

Moderate and Severe Haemophilia Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03237273
• Other study ID #: 63143
• Status: Not yet recruiting
• Phase: N/A
• First received: July 31, 2017
• Last updated: July 31, 2017
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Collette Pigden, MSc
• Phone: 020 7188 7188
• Email: collette.pigden[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A
• Moderate and Severe Haemophilia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any change in treatment	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	12 months
Secondary	% joints with normal HJHS and abnormal HEAD-US score	% joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately	12 months
Secondary	% joints with abnormal HJHS and normal HEAD-US score	% joints with abnormal HJHS and normal HEAD-US score	12 months