Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand DiseaseHEMICOGNCT06090201
Severe Congenital Hemostatic Defects, Cerebral MIcrobleeds and COGnition
An observational study of Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand Disease, run by University Hospital, Lille at 1 site in France.
Trial 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 magnetic resonance imaging (MRI) techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand Disease
- What is being tested?
- 3-Tesla brain MRI and a comprehensive neuropsychological assessment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2023to 10 Aug 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participation in this study (with the delivery of an information note) will be offered to all eligible patients during a follow-up visit related to haemophilia or Von Willebrand Disease within the Haemostasis-Transfusion Department of the Lille University Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
chu de Lille
Lille
Laurent PUY, Dr, 00 33 3 20 44 68 14, laurent.puy@univ-lille.fr
About this study
Official title: Cerebral Microbleeds in Severe Congenital Hemostatic Defects: Prevalence and Impact on Cognition
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.
- Being tested
- 3-Tesla brain MRI and a comprehensive neuropsychological assessment
- Keywords
- Cerebral microbleeds (CMBs), Congenital haemophilia, Congenital von Willebrand disease (vWd), Cerebral small vessel disease (SVD), Cognition, Magnetic resonance imaging (MRI)
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Tesla brain MRI and a comprehensive neuropsychological assessmentOther
Patients with a moderate to severe form of congenital haemophilia A or B or a severe form of von Willebrand disease will be consecutively recruited in the study during a routine follow-up visit at the Haemostasis and Transfusion Department of the Lille University Hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with at least one CMB on 3-Tesla brain MRI (using specific sequences dedicated to the detection of CMBs).
Measured: Within 3 Months after inclusion
Secondary outcomes (10)
Number and anatomical location (deep/lobar) of CMBs on 3-Tesla brain MRI
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- MoCA
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
Memory: The free and cued selective reminding test (FCSRT, French version) ; The Wechsler digit span task will be used to examine verbal short term and working memory.
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- Processing speed and attention: digit symbol coding subtest of WAIS 4; the Continuous Performance Test (third edition, CPT3).
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- Executive function: The categorical and literal fluency test and the Trail-Making Test (TMT).
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- Social cognition: MINI-SEA)
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- Depression: CES-D
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- Anxiety: HAM-A
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- Fatigue: The Chalder Fatigue Scale
Measured: Within 3 Months after inclusion
Multi-domain cognitive performances assessed by standardized scales as follows
- Sleepiness and the impact of sleep disorders: The Epworth Sleepiness Scale
Measured: Within 3 Months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start10 Nov 2023
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090201
- Sponsor's protocol ID
- 2022_0601
- Acronym
- HEMICOG
- Status last verified
- May 2026
- First submitted
- 5 Oct 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No