Detecting Subclinical Joint Bleeding and Inflammation in Haemophilia
- Conditions
- haemophiliahemophilia10064477
- Registration Number
- NL-OMON55572
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 79
- Patient provides written, informed consent;
- Born
o Between January 1, 1970 and January 1, 1988 (METC 11-442)
o After January 1, 1988 and age >=16 years
- Severe haemophilia A (FVIII< 0.01 IU/ml)
- Treated at the Van Creveldkliniek, UMC Utrecht
- History of inhibitor development (>= 5 Bethesda Units* (BU) at any time or 1-
5 BU for >=1 year)
- Patients with a history of a major joint bleed in the three months prior to
assessment
- Patients with a history of a minor joint bleed in the month prior to
assessment
- MRI exclusion criteria, including MRI contraindications as per usual clinical
care, such as claustrophobia and metal or electronic implants not compatible
with MRI.
*One Bethesda unit (BU) is defined as that amount of inhibitor that results in
50% re-sidual FVIII:C activity in tested plasma mixed with an equal volume of a
normal plasma pool (NPP) after incubation for 2 hours at 37°C.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part I:<br /><br>At joint level: Radiological signs of subclinical inflammation defined as<br /><br>synovial hypertrophy on ultrasound (or MRI in case of inconclusive ultrasound<br /><br>findings).<br /><br>At patient level: Biomarkers for inflammation and biomarkers for cartilage and<br /><br>bone turnover in blood and urine. The biomarkers comprising origin of different<br /><br>joint tissues will be selected and adopted based on the literature on<br /><br>osteoarthritis, which is a rapidly changing area of research.<br /><br><br /><br>Part II:<br /><br>Radiological signs of subclinical bleeding defined as: synovial hypertrophy,<br /><br>MRI detected iron / haemosiderin deposits in joints without a history of<br /><br>bleeding at joint level. </p><br>
- Secondary Outcome Measures
Name Time Method <p>At joint level:<br /><br>- The diagnostic value of physical examination (swelling, warmth) in comparison<br /><br>with synovial hypertrophy detected with ultrasound.<br /><br>- Occurrence of MRI detectable blood products in joints with joint effusion on<br /><br>ultrasound in the absence of a clinical bleed. </p><br>