NCT06090201Recruiting
Severe Congenital Hemostatic Defects, Cerebral MIcrobleeds and COGnition
Cerebral Microbleeds in Severe Congenital Hemostatic Defects: Prevalence and Impact on Cognition
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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 disease (vWD), populations at high risk of ICH, are unique conditions that may give us further insights into a potential role of haemostatic defects in the pathophysiology of CMBs. CMBs might be the missing link between severe haemostatic defects, ICH risk and cognitive function. We hypothesized that severe congenital haemostatic defects could contribute to an increased prevalence and number of CMBs, with an impact on cognition in adulthood.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 5 Oct 2023
- Start date
- Nov 2023
- Primary completion date
- Aug 2026
- Lead sponsor
- University Hospital, Lille
- Diseases
- Haemophilia
- NCT number
- NCT06090201
What you commit to
- Study type: Observational
- Planned participants: 200
- From Nov 2023 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV infection to avoid a bias towards severe multifactorial neurological complications
- Other known coagulation disorder(s) in addition to haemophilia or von Willebrand disease
Other
- Contraindication for brain MRI
- Lack of informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.