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

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ClinicalTrials.gov Identifier: NCT03237273
Recruitment Status : Not yet recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Moderate and Severe Haemophilia Other: HEAD-US scoring system Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : December 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Single
All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist
Other: HEAD-US scoring system
HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage




Primary Outcome Measures :
  1. Any change in treatment [ Time Frame: 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 Outcome Measures :
  1. % joints with normal HJHS and abnormal HEAD-US score [ Time Frame: 12 months ]
    % joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately

  2. % joints with abnormal HJHS and normal HEAD-US score [ Time Frame: 12 months ]
    % joints with abnormal HJHS and normal HEAD-US score



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237273


Contacts
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Contact: Collette Pigden, MSc 020 7188 7188 ext 52464 collette.pigden@gstt.nhs.uk
Contact: Paschos, MSc 020 7188 2775 christos.paschos@gstt.nhs.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Pfizer
Investigators
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Principal Investigator: Gerard Dolan, MD Guys and St. Thomas' NHS Foundation Trust

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03237273     History of Changes
Other Study ID Numbers: 63143
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be analysed and reported as results not individual data

Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn