D66 M65
Conditions
Interventions
Group 1: In paediatric patients with haemophilia A, the elbow, knee and ankle joints are examined at one measurement point using standardized ultrasound and clinical joint examinations. In addition, t
Sponsors
Universtätsklinikum Bonn
Eligibility
Sex/Gender
Male
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: o Suffers from moderate or severe hemophilia A, also with inhibitor or joint surgery in the past o Complete documentation of the severity of hemophilia, treatment history (last 12 months) and bleeding events (last 12 months), inhibitor status (at the time of enrollment in the study and in the medical history) o Submission of written consent to participate in the study
Exclusion criteria
Exclusion criteria: o Patients suffering from other bleeding disorders that conflict with the research question o Patients participating in clinical trials with investigational medicinal products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of synovitis in at least one of the patient's joints using the HEAD-US (a score of 1 (mild/moderate) or 2 (severe) in the activity (synovitis) dimension of the HEAD-US according to Martinoli et al. 2013). | — |
Secondary
| Measure | Time frame |
|---|---|
| o Pain interference (PROMIS Parent-Proxy-25) - (score 8-40 points - converted to a T-score / numerical rating scale (NRS) 0-10). o Subjective physical performance (Haemophilia Activities List-Pediatric) - (score 0-100) - higher scores indicate better functional status. o Clinical joint examination according to De la Corte-Rodriguez et al. (swelling, pain, hemarthrosis in the last 6 months) [21] - (score 0-124) - a higher score indicates a worse joint status. o Joint damage confirmed in the cartilage (0-4) or bone (0-2) dimension with a minimum score =1 of the HEAD-US according to Martinoli et al. 2013. o Complete evaluation of the HEAD-US examination, which includes the extent of synovitis, effusion, cartilage and bone. Individual and joint-based subgroup analyses are performed to examine the four dimensions according to Martinoli et al. 2013. o General medical history questionnaire (diseases, pain medication, surgery, hemophilia-related clinical data) o Haemophilia treatment in the last twelve months (medication on demand/prophylaxis/non-factor therapy/EHL or SHL therapy) o Bleeding events in the last twelve months (traumatic or spontaneous) | — |
Countries
Austria, Germany
Contacts
Public ContactAndreas Strauss
Universitätsklinikum Bonn
Outcome results
None listed