Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA
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: Vitamin B12.
- Кому может быть актуально
- Состояния в реестре: Sickle Cells Patients. Базовые параметры: 2 лет — 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA , a Prospective Study at Reims University Hospital
Обзор
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The sickle cells anemia is a monogenic disease linked to the presence of Hemoglobin S due to a mutation in the Hemoglobin Beta chain. The lack of circulating oxygen induces a polymerization of the Hemoglobin S which change the red cell conformation into sickle. Those cells interact and causes vaso-occlusive crisis (CVO). The MEOPA is a medical gas used as an antalgic and a sedative especially in sickle cells disease patients. The nitrous oxide, oxide the cobalt ion in the vitamin B12 which inactivate it irreversibly creating a functional deficiency. During the metabolism of vitamin B12, homocysteine is transformed in methionine which is used in to form the myelin sheath and helped in producing DNA. Numerous studies already shown that the longer the exposition to MEOPA is the greater the functional deficiency of vitamin B12 occur. A few studies shown a symptomatic deficiency of vitamin B12 due to the exposition of MEOPA in sickle cells patient but there is no explanation on the necessary amount of exposure or if some patients are more at risk. When there is a deficiency of vitamin B12 the symptoms can go from a simple orthostatic hypotension to a combined spinal sclerosis. The participation to the study will be proposed to every patient hospitalized for a CVO in the follow up of the emergency room visit or directly in pediatric reanimation. During a usual blood test, a small amount of blood (4mL) will be collected in addition to dose the Vitamin B12, the vitamin B9, the homocysteine, and the methionine. A small amount of urine will also be collected to dose the methylmalonic acid, all those elements are a part of the metabolism of B12 vitamin. The same sample will be taken on the day of departure of the hospital. During the hospitalization the pain management, a daily neurological exam, and the exposition to the MEOPA will be assessed meticulously. An appointment will take place at 7 days and at one month after the hospital departure to evaluate the possible neurological defect. Each patient can only be included once.
Вмешательства
- Другое Vitamin B12
Quantification of Vitamin B12
Первичные конечные точки
- Proportion of patients who will present a Vitamin B12 deficiency [Срок оценки: Day 15]
Критерии участия
Критерии включения
- Sickle cells patient
- Age between 2 and 18 years old
- Being affiliated with social security
Критерии исключения
- Having a neurological defect prior to the study
- Being against the collection of blood or data
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 Reims — Reims
Идентификаторы
NCT: NCT06581900 · PA24081*