<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03237273</url>
  </required_header>
  <id_info>
    <org_study_id>63143</org_study_id>
    <nct_id>NCT03237273</nct_id>
  </id_info>
  <brief_title>HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ultrasound represents a promising technique for the assessment of joint health in persons&#xD;
      with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy&#xD;
      Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating&#xD;
      joint ultrasound in the routine assessment of PWH through the use of a simplified scoring&#xD;
      system. The inter-operator reliability of the technique among European haemophilia treaters&#xD;
      has been validated and described elsewhere. Further work is needed to assess the real-world&#xD;
      impact of ultrasound on disease management and treatment decision-making.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are seen routinely in clinic by specialist haemophilia physiotherapists who assess&#xD;
      the patients using the Haemophilia Joint Health Score tool (HJHS). Trial participants will be&#xD;
      seen during their routine clinic visits and will be seen by a clinician and the&#xD;
      physiotherapist who will carry out the routine assessment along with the HEAD-US scan.&#xD;
&#xD;
      Patients will be seen a maximum of 4 times throughout the year from registration of the first&#xD;
      patient, according to their visit schedule, but will only be scanned at the first visit.&#xD;
&#xD;
      Results will be analysed to determine if the treatment decision-making is influenced by the&#xD;
      results of the scan&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any change in treatment</measure>
    <time_frame>12 months</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% joints with normal HJHS and abnormal HEAD-US score</measure>
    <time_frame>12 months</time_frame>
    <description>% joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% joints with abnormal HJHS and normal HEAD-US score</measure>
    <time_frame>12 months</time_frame>
    <description>% joints with abnormal HJHS and normal HEAD-US score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Moderate and Severe Haemophilia</condition>
  <arm_group>
    <arm_group_label>Single</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HEAD-US scoring system</intervention_name>
    <description>HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage</description>
    <arm_group_label>Single</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate (FVIII/FIX:C 1-5%) and severe (FVIII/FIX: C &lt;1%) patients with haemophilia A&#xD;
             or B aged ≥ 6 years&#xD;
&#xD;
          -  On demand or prophylaxis treatment regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Joints with a previous history of surgery&#xD;
&#xD;
          -  Joints with damage as a result of causes other than haemophilia-related bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerard Dolan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guys and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Collette Pigden, MSc</last_name>
    <phone>020 7188 7188</phone>
    <phone_ext>52464</phone_ext>
    <email>collette.pigden@gstt.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paschos, MSc</last_name>
    <phone>020 7188 2775</phone>
    <email>christos.paschos@gstt.nhs.uk</email>
  </overall_contact_backup>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be analysed and reported as results not individual data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03237273
org study id: 63143
nct id: NCT03237273
lead sponsor: 
collaborator: 
has dmc: No
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.
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Any change in treatment
time frame: 12 months
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
measure: % joints with normal HJHS and abnormal HEAD-US score
time frame: 12 months
description: % joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately
measure: % joints with abnormal HJHS and normal HEAD-US score
time frame: 12 months
description: % joints with abnormal HJHS and normal HEAD-US score
arm group label: Single
arm group type: Experimental
description: All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist
intervention type: Other
intervention name: HEAD-US scoring system
description: HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage
arm group label: Single
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Gerard Dolan, MD
role: Principal Investigator
affiliation: Guys and St Thomas' NHS Foundation Trust
last name: Collette Pigden, MSc
phone: 020 7188 7188
phone ext: 52464
email: collette.pigden@gstt.nhs.uk
last name: Paschos, MSc
phone: 020 7188 2775
email: christos.paschos@gstt.nhs.uk
responsible party type: Sponsor
mesh term: Hemophilia A
sharing ipd: No
ipd description: Data will be analysed and reported as results not individual data