Status:
NOT_YET_RECRUITING
Severe Congenital Hemostatic Defects, Cerebral MIcrobleeds and COGnition
Lead Sponsor:
University Hospital, Lille
Conditions:
Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand Disease
Eligibility:
All Genders
18+ years
Brief Summary
Cerebral microbleeds (CMBs) are haemosiderin deposits, resulting from the leakage of erythrocytes from small cerebral vessels, which can be detected noninvasively using susceptibility-sensitive magnet...
Eligibility Criteria
Inclusion
- Male or female, older than 18 years old, no upper age limit
- Adult patients with a severe congenital haemostatic defect
- Severe or moderate congenital haemophilia A (or B) defined as \<5 IU/dL (\<5%) endogenous FVIII (FIX) activity at screening
- Severe von Willebrand disease defined as VWF: Act ≤15IU/dL (\<15%) at screening
- Ability of the participant to provide signed and dated informed consent
Exclusion
- Contraindication for brain MRI
- HIV infection to avoid a bias towards severe multifactorial neurological complications
- Other known coagulation disorder(s) in addition to haemophilia or von Willebrand disease
- Lack of informed consent
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06090201
Start Date
November 1 2023
End Date
August 1 2026
Last Update
October 19 2023
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