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Severe Congenital Hemostatic Defects, Cerebral MIcrobleeds and COGnition

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Lille
NCT06090201 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cerebral microbleeds (CMBs) are haemosiderin deposits, resulting from the leakage of erythrocytes from small cerebral vessels, which can be detected noninvasively using susceptibility-sensitive magnetic resonance imaging (MRI) techniques. CMBs are commonly observed in daily practice: their prevalence range from five percent in healthy individuals over 65 years old to 50% in patients with a history of stroke. CMBs are associated with intracerebral hemorrhage (ICH) and also cognitive impairment and dementia. The pathophysiology of CMBs is thought to primarily involve damage to brain microvasculature but the exact underlying cascade of events, including a potential role for haemostasis, has yet to be elucidated. Haemostatic defects (congenital or acquired) may contribute to an increased number and importance of CMBs. Congenital bleeding disorders such as haemophilia or von Willebrand disea

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📋 Eligibility rules (as published)
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
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What it tests

  • 3-Tesla brain MRI and a comprehensive neuropsychological assessment
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Where

1 site
chu de Lille
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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