The Use of GFAP and UCH-L1 Biomarkers in Clinical Practice for the Management of Mild Traumatic Brain Injury (BIO-TC-L)
Mild traumatic brain injury (mTBI) is a frequent reason for emergency department visits. Although most patients have a normal brain CT scan, this examination is still widely ordered, exposing patients to radiation, overloading imaging services and increasing care costs. The decision to perform a brain CT scan is usually based on validated clinical decision rules, such as the Canadian CT Head Rule (CCHR) or the New Orleans Criteria (NOC). However, several studies including a recent meta-analysis suggest significant CT overuse in the management of mTBI.
In recent years, biomarkers specific to brain injury mainly Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) have shown their ability to reliably rule out the presence of clinically significant intracranial injuries.
The combined use of GFAP and UCH-L1 has been recommended by the French Society of Anesthesia and Intensive Care Medicine (SFAR) and the French Society of Emergency Medicine (SFMU) in patients with mild traumatic brain injury at intermediate risk of intracranial bleeding, in order to limit the number of brain CT scans. Although prospective observational studies have evaluated the value of using these biomarkers, no study has evaluated their implementation in routine clinical practice.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
The study will be conducted in the Emergency Department (ED) of Grenoble University Hospital.
The main objective of this prospective, single-center, observational study is therefore to analyze the use of GFAP and UCH-L1 biomarkers in routine clinical practice at Grenoble University Hospital to confirm their clinical utility and safety.
All adult patients presenting to the Grenoble Alpes University Hospital emergency department for mild traumatic brain injury will be enrolled and analyzed during the study period.
Data will be collected from electronic medical records. To assess patient's outcomes 1 month after their emergency department visit, a follow-up will telephone call will be conducted for the subgroup of patients who had a negative biomarker result without an initial CT scan.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Prudence MABIALA MAKELE, PhD
- Номер телефона: 0033476766784
- Электронная почта: pmabialamakele@chu-grenoble.fr
Учебное резервное копирование контактов
- Имя: Nicolas SEGOND, MD PhD
- Номер телефона: 0033476766784
- Электронная почта: NSegond@chu-grenoble.fr
Места учебы
-
-
Isere
-
Grenoble, Isere, Франция
- Grenoble University Hospital
-
Контакт:
- Prudence MABIALA MAKELE, PhD
- Номер телефона: 0033476766784
- Электронная почта: pmabialamakele@chu-grenoble.fr
-
Контакт:
- Nicolas SEGONG, MD PhD
- Номер телефона: 0033476766784
- Электронная почта: NSegond@chu-grenoble.fr
-
Главный следователь:
- Nicolas SEGOND, MD PhD
-
Младший исследователь:
- Damien VIGLINO, MD PhD
-
Младший исследователь:
- Dorra GUERGOUR, MD PhD
-
Младший исследователь:
- Carole CHIRICA, MD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Adult patient admitted in the Emergency department of Grenoble University Hospital for mild traumatic brain injury over a 4-month enrollment period from the start of the study
Описание
Inclusion Criteria:
- Patients over 18 years admitted to the emergency department of Grenoble University Hospital for mild traumatic brain injury over a 4-month enrollment period from the start of the study
Exclusion Criteria:
- Patients with penetrating head injury
- Patients with a Glasgow Coma Scale score between 3 and 12 on admission to the emergency department
- Patients unable to communicate or who do not speak French
- Persons covered by Articles L1121-6 and L1121-8 of the French Public Health Code (CSP) (persons deprived of liberty by administrative or judicial decision, unable to understand the protocol)
- Patients already enrolled in the study during a previous emergency department visit
- Patients not affiliated to the french social security system
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
All adult patients admitted in the Emergency Department for mild traumatic brain injury
All adult patients presenting to the Grenoble Alpes University Hospital emergency department for mild traumatic brain injury will be enrolled and analyzed during the study period |
To assess patient's outcomes 1 month after their emergency department visit, a follow-up will telephone call will be conducted for the subgroup of patients who had a negative biomarker result without an initial CT scan.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The proportion of patients who underwent GFAP and UCH-L1 testing, and in whom a brain CT scan was avoided following a negative result in accordance with current guidelines
Временное ограничение: 1 month
|
The proportion of patients who underwent GFAP and UCH-L1 testing, and in whom a brain CT scan was avoided following a negative result in accordance with current guidelines |
1 month
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of protocol deviations
Временное ограничение: 24 hours
|
Proportion of protocol deviations (TBI wrongly classified as mild, Biomarkers wrongly measured, Biomarkers not measured when indicated, Brain CT scan wrongly performed, Brain CT scan not performed when indicated). |
24 hours
|
|
Calculation of the time from emergency department arrival to biomarker ordering
Временное ограничение: 24 hours
|
Calculation of the time from emergency department arrival to biomarker ordering (the time from biomarker ordering to result reporting). |
24 hours
|
|
Assess the safety of using brain biomarkers in routine clinical practice, based on the 1-month clinical outcome of patients who had a negative measurement without an initial CT scan
Временное ограничение: 1 month
|
Proportion of patient who returned to the emergency department or to their general practitioner for a reason related to head trauma within one month of the initial visit. And proportion of CT scans showing a significant intracranial injury among those performed within the month |
1 month
|
|
Evaluate the prognostic performance of brain biomarkers for ruling out intracranial injury, in the overall population and by age
Временное ограничение: 1 month
|
Calculation of prognostic performance indicators (area under the curve, sensitivity, specificity, positive and negative predictive values) of brain biomarkers for ruling out intracranial injury, in the overall population and by age |
1 month
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Nicolas SEGOND, MD PhD, University Hospital, Grenoble
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 38RC26.0261
- IDRCB : 2026-A01713-48 (Другой идентификатор: CPP Est III (French Ethics Committees))
Планирование данных отдельных участников (IPD)
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Описание плана IPD
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.
In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
Сроки обмена IPD
At the time of publication
Критерии совместного доступа к IPD
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. Moreover, In accordance with the French law n ° 2002-303 of March 4th, 2002
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .