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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEAD-US scoring system | Other | HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| % joints with normal HJHS and abnormal HEAD-US score | % joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately | 12 months |
| % joints with abnormal HJHS and normal HEAD-US score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Collette Pigden, MSc | Contact | 020 7188 7188 | 52464 | collette.pigden@gstt.nhs.uk |
| Paschos, MSc | Contact | 020 7188 2775 | christos.paschos@gstt.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gerard Dolan, MD | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
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Data will be analysed and reported as results not individual data
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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% joints with abnormal HJHS and normal HEAD-US score
| 12 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |