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

Primary Purpose

Moderate and Severe Haemophilia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HEAD-US scoring system
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Moderate and Severe Haemophilia

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    % joints with normal HJHS and abnormal HEAD-US score
    % joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately
    % joints with abnormal HJHS and normal HEAD-US score
    % joints with abnormal HJHS and normal HEAD-US score

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    July 31, 2017
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03237273
    Brief Title
    HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate and Severe Haemophilia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single
    Arm Type
    Experimental
    Arm Description
    All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist
    Intervention Type
    Other
    Intervention Name(s)
    HEAD-US scoring system
    Intervention Description
    HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage
    Primary Outcome Measure Information:
    Title
    Any change in treatment
    Description
    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
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    % joints with normal HJHS and abnormal HEAD-US score
    Description
    % joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately
    Time Frame
    12 months
    Title
    % joints with abnormal HJHS and normal HEAD-US score
    Description
    % joints with abnormal HJHS and normal HEAD-US score
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Collette Pigden, MSc
    Phone
    020 7188 7188
    Ext
    52464
    Email
    collette.pigden@gstt.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paschos, MSc
    Phone
    020 7188 2775
    Email
    christos.paschos@gstt.nhs.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerard Dolan, MD
    Organizational Affiliation
    Guys and St Thomas' NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will be analysed and reported as results not individual data

    Learn more about this trial

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

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