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

NCT03237273

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Moderate and Severe Haemophilia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Joints with a previous history of surgery


- Joints with damage as a result of causes other than haemophilia-related bleeding

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Moderate and Severe HaemophiliaHEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound
NCT03237273
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound
Official Title  ICMJE HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound on Disease Management and Treatment Decision-making in Moderate and Severe Haemophilia
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Moderate and Severe Haemophilia
Intervention  ICMJE Other: HEAD-US scoring system
HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage
Study Arms  ICMJE Experimental: Single
All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist
Intervention: Other: HEAD-US scoring system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03237273
Other Study ID Numbers  ICMJE 63143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Data will be analysed and reported as results not individual data
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor  ICMJE Guy's and St Thomas' NHS Foundation Trust
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Gerard Dolan, MDGuys and St Thomas' NHS Foundation Trust
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP