HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound
NCT03237273
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Adult Trials: 18+ Years
- 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
- Joints with a previous history of surgery
- Joints with damage as a result of causes other than haemophilia-related bleeding
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| 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 | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| 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 |
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| 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 | |||||