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Идёт набор NCT06090201

Severe Congenital Hemostatic Defects, Cerebral MIcrobleeds and COGnition

— Наблюдательное Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 3-Tesla brain MRI and a comprehensive neuropsychological assessment.
Кому может быть актуально
Состояния в реестре: Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Cerebral Microbleeds in Severe Congenital Hemostatic Defects: Prevalence and Impact on Cognition

Обзор

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.

Вмешательства

  • Другое 3-Tesla brain MRI and a comprehensive neuropsychological assessment
    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.

Первичные конечные точки

  • The rate of patients with at least one CMB on 3-Tesla brain MRI (using specific sequences dedicated to the detection of CMBs). [Срок оценки: Within 3 Months after inclusion]
Вторичные конечные точки (10)
  • Number and anatomical location (deep/lobar) of CMBs on 3-Tesla brain MRI [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]
  • Multi-domain cognitive performances assessed by standardized scales as follows [Срок оценки: Within 3 Months after inclusion]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • chu de Lille — Lille

Идентификаторы

NCT: NCT06090201 · 2022_0601

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗