Cerebral Microbleeds in People with Severe Congenital Bleeding Disorders
Official title: Cerebral Microbleeds in Severe Congenital Hemostatic Defects: Prevalence and Impact on Cognition
Run by University Hospital, Lille · NCT06090201 · Data updated 2026-11-12
This study checks brain MRI and cognitive tests to see how common cerebral microbleeds are in adults with severe congenital bleeding disorders like hemophilia and von Willebrand disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | November 10, 2023 |
| Main results expected | August 10, 2026 |
| Study ends | August 10, 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06090201 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a confirmed severe congenital bleeding disorder (severe hemophilia A/B or severe von Willebrand disease) who can undergo MRI and provide informed consent.
✕Probably not a fit
Individuals without cerebral microbleeds or with atypical presentations may see limited direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses 3-Tesla brain MRI and a comprehensive neuropsychological assessment to investigate the prevalence and implications of cerebral microbleeds in adults with severe congenital haemostatic defects. It aims to explore how these microbleeds relate to cognitive performance and brain small vessel disease. Participants are adults with confirmed severe congenital hemophilia A or B or severe von Willebrand disease, who can provide informed consent and tolerate MRI. Data collection focuses on imaging markers of microbleeds and neurocognitive outcomes to enhance understanding of bleeding disorders' neurological impact.
Why it matters
Potential benefit: If successful, findings could improve understanding of brain changes in congenital bleeding disorders and inform future risk assessment and monitoring strategies.
How similar studies have gone: Previous research has shown associations between microbleeds and cognitive impairment in broader populations, but this specific congenital-bleeding-disorder focus is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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chu de Lille
Lille, France Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.