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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Prudence MABIALA MAKELE, PhD
- Telefonnummer: 0033476766784
- E-Mail: pmabialamakele@chu-grenoble.fr
Studieren Sie die Kontaktsicherung
- Name: Nicolas SEGOND, MD PhD
- Telefonnummer: 0033476766784
- E-Mail: NSegond@chu-grenoble.fr
Studienorte
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Isere
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Grenoble, Isere, Frankreich
- Grenoble University Hospital
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Kontakt:
- Prudence MABIALA MAKELE, PhD
- Telefonnummer: 0033476766784
- E-Mail: pmabialamakele@chu-grenoble.fr
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Kontakt:
- Nicolas SEGONG, MD PhD
- Telefonnummer: 0033476766784
- E-Mail: NSegond@chu-grenoble.fr
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Hauptermittler:
- Nicolas SEGOND, MD PhD
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Unterermittler:
- Damien VIGLINO, MD PhD
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Unterermittler:
- Dorra GUERGOUR, MD PhD
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Unterermittler:
- Carole CHIRICA, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: 1 month
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of protocol deviations
Zeitfenster: 24 hours
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nicolas SEGOND, MD PhD, University Hospital, Grenoble
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 38RC26.0261
- IDRCB : 2026-A01713-48 (Andere Kennung: CPP Est III (French Ethics Committees))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
At the time of publication
IPD-Sharing-Zugriffskriterien
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
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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