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

NCT ID: NCT03237273

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

Conditions

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Moderate and Severe Haemophilia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single

All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist

Group Type EXPERIMENTAL

HEAD-US scoring system

Intervention Type OTHER

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

Interventions

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HEAD-US scoring system

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard Dolan, MD

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Central Contacts

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Collette Pigden, MSc

Role: CONTACT

020 7188 7188 ext. 52464

Paschos, MSc

Role: CONTACT

020 7188 2775

Other Identifiers

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63143

Identifier Type: -

Identifier Source: org_study_id

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