S100B Protein: a Diagnostic Aid in Episodes of Transient Loss of Consciousness?

Официальное название

Diagnostic Performance of S100B Protein Measurement in Episodes of Transient Loss of Consciousness: a Prospective Cohort Study

Обзор

S100B protein is a biomarker produced mainly by astrocytes and released into the bloodstream in the event of brain injury, with levels rising rapidly and markedly in acute conditions such as traumatic brain injury, stroke, or epileptic seizures, before declining quickly. Increased S100B levels following a convulsive seizure have been reported, suggesting potential value in distinguishing epilepsy from other causes; however, its use in the etiological assessment of transient loss of consciousness has not yet been studied. Loss of consciousness represents a common reason for Emergency Department visits and involves a wide range of causes, making diagnosis challenging due to often limited clinical history and resulting in numerous investigations. A biomarker such as S100B could help guide diagnosis more rapidly, particularly in distinguishing epilepsy from other causes, thereby reducing the need for additional tests and shortening hospital stay. To date, no study has evaluated the performance of S100B measurement in the etiological workup of transient loss of consciousness. The hypothesis underlying this study is that measurement of S100B levels in the Emergency Department could help differentiate epileptic seizures from other etiologies, particularly cardiac causes, and thus reduce additional investigations and hospital stay. This prospective observational study primarily aims to assess the diagnostic performance of S100B measurement for identifying epilepsy compared with other causes of transient loss of consciousness in adult patients presenting to the Emergency Department for this reason. The study will begin on April 30 and will last 15 months. In practice, eligible patients who do not oppose participation will undergo an additional blood sample at the time of initial sampling required for clinical management, with this sample used to measure plasma S100B levels; patient management will otherwise remain identical to standard care. Three months after the Emergency Department visit, an adjudication committee composed of a neurologist, a cardiologist, and an emergency physician will determine the final diagnosis based on all available data, including any additional investigations performed after the initial visit. The primary endpoint is the area under the ROC curve (AUROC) of S100B measurement, evaluating its ability to discriminate epilepsy from other causes of transient loss of consciousness.

Первичные конечные точки

• Area under the ROC curve (AUROC) of S100B measurement, assessing its ability to discriminate epilepsy from other causes of transient loss of consciousness [Срок оценки: 15 Months]

Вторичные конечные точки (7)

• Determination of the optimal S100B threshold for the diagnosis of epilepsy using Youden's index [Срок оценки: 15 months]
• Assessment of the diagnostic performance associated with the optimal S100B threshold for epilepsy diagnosis (sensitivity, specificity, positive predictive value, and negative predictive value). [Срок оценки: 15 months]
• Subgroup analyses based on adjudicated etiological diagnoses [Срок оценки: 15 Months]
• Analysis of S100B levels according to patient comorbidities [Срок оценки: 15 months]
• Analysis of results based on the time between symptom onset and sample collection (in hours). [Срок оценки: 15 months]
• Analysis of results according to patient age (<65 years, 65-79 years, and ≥80 years). [Срок оценки: 15 months]
• Analysis of results based on the occurrence of head trauma during the episode and, if applicable, the time between the trauma and the measurement of S100B (in hours). [Срок оценки: 15 months]

Критерии участия

Критерии включения

• • Adult ≥ 18 years old

• Presentation to the Emergency Department of Henri Mondor University Hospital
• History of loss of consciousness
• Undergoing a blood test as part of Emergency Department care
• Covered by social security
• Has agreed to participate in the study

Критерии исключения

• Symptoms occurring more than 12 hours ago

• History of head trauma without brain imaging performed
• History of head trauma with intracranial bleeding confirmed on brain imaging
• Refusal to participate in the study
• Pregnant and/or breastfeeding women
• Individuals unable to provide consent, particularly due to cognitive impairment
• Individuals under legal protection:
• Placed under guardianship
• Deprived of liberty (incarcerated or hospitalized without 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

• Hôpital Henri Mondor — Créteil

Идентификаторы

NCT: NCT07527754 · APHP251504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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