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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Prudence MABIALA MAKELE, PhD
- Numero di telefono: 0033476766784
- Email: pmabialamakele@chu-grenoble.fr
Backup dei contatti dello studio
- Nome: Nicolas SEGOND, MD PhD
- Numero di telefono: 0033476766784
- Email: NSegond@chu-grenoble.fr
Luoghi di studio
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Isere
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Grenoble, Isere, Francia
- Grenoble University Hospital
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Contatto:
- Prudence MABIALA MAKELE, PhD
- Numero di telefono: 0033476766784
- Email: pmabialamakele@chu-grenoble.fr
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Contatto:
- Nicolas SEGONG, MD PhD
- Numero di telefono: 0033476766784
- Email: NSegond@chu-grenoble.fr
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Investigatore principale:
- Nicolas SEGOND, MD PhD
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Sub-investigatore:
- Damien VIGLINO, MD PhD
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Sub-investigatore:
- Dorra GUERGOUR, MD PhD
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Sub-investigatore:
- Carole CHIRICA, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of protocol deviations
Lasso di tempo: 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
|
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Calculation of the time from emergency department arrival to biomarker ordering
Lasso di tempo: 24 hours
|
Calculation of the time from emergency department arrival to biomarker ordering (the time from biomarker ordering to result reporting). |
24 hours
|
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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
Lasso di tempo: 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
|
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Evaluate the prognostic performance of brain biomarkers for ruling out intracranial injury, in the overall population and by age
Lasso di tempo: 1 month
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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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nicolas SEGOND, MD PhD, University Hospital, Grenoble
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 38RC26.0261
- IDRCB : 2026-A01713-48 (Altro identificatore: CPP Est III (French Ethics Committees))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
At the time of publication
Criteri di accesso alla condivisione 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
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
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