NL-OMON55572
Completed
N/A
Detecting Subclinical Joint Bleeding and Inflammation in Haemophilia - BEGIN-study
niversitair Medisch Centrum Utrecht0 sites79 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 79
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patient provides written, informed consent;
- •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
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
- •\- Patients with a history of a minor joint bleed in the month prior to
- •\- MRI exclusion criteria, including MRI contraindications as per usual clinical
- •care, such as claustrophobia and metal or electronic implants not compatible
- •\*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.
Outcomes
Primary Outcomes
Not specified
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