Detecting Subclinical Joint Bleeding and Inflammation in Haemophilia

Detecting Subclinical Joint Bleeding and Inflammation in Haemophilia - BEGIN-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55572

Enrollment

Registered

2019-07-25

Start date

2019-12-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haemophilia hemophilia

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Part I: At joint level: Radiological signs of subclinical inflammation defined as synovial hypertrophy on ultrasound (or MRI in case of inconclusive ultrasound findings). At patient level: Biomarkers for inflammation and biomarkers for cartilage and bone turnover in blood and urine. The biomarkers comprising origin of different joint tissues will be selected and adopted based on the literature on osteoarthritis, which is a rapidly changing area of research. Part II: Radiological signs of subclinical bleeding defined as: synovial hypertrophy, MRI detected iron / haemosiderin deposits in joints without a history of bleeding at joint level.	—

Measure

Time frame

Part I: At joint level: Radiological signs of subclinical inflammation defined as synovial hypertrophy on ultrasound (or MRI in case of inconclusive ultrasound findings). At patient level: Biomarkers for inflammation and biomarkers for cartilage and bone turnover in blood and urine. The biomarkers comprising origin of different joint tissues will be selected and adopted based on the literature on osteoarthritis, which is a rapidly changing area of research. Part II: Radiological signs of subclinical bleeding defined as: synovial hypertrophy, MRI detected iron / haemosiderin deposits in joints without a history of bleeding at joint level.

—

Secondary

Measure	Time frame
At joint level: - The diagnostic value of physical examination (swelling, warmth) in comparison with synovial hypertrophy detected with ultrasound. - Occurrence of MRI detectable blood products in joints with joint effusion on ultrasound in the absence of a clinical bleed.	—

Countries

Netherlands

Outcome results