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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biomarkers; Mild Traumatic Brain Injury (mTBI)
• Intervention / Treatment: Other: Follow-up telephone call after one month

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Prudence MABIALA MAKELE, PhD; Phone Number: 0033476766784; Email: pmabialamakele@chu-grenoble.fr
• Study Contact Backup: Name: Nicolas SEGOND, MD PhD; Phone Number: 0033476766784; Email: NSegond@chu-grenoble.fr

Study Locations

• France
  • Isere
    • Grenoble, Isere, France
      • Grenoble University Hospital
      • Contact: Prudence MABIALA MAKELE, PhD; Phone Number: 0033476766784; Email: pmabialamakele@chu-grenoble.fr
      • Contact: Nicolas SEGONG, MD PhD; Phone Number: 0033476766784; Email: NSegond@chu-grenoble.fr
      • Principal Investigator: Nicolas SEGOND, MD PhD
      • Sub-Investigator: Damien VIGLINO, MD PhD
      • Sub-Investigator: Dorra GUERGOUR, MD PhD
      • Sub-Investigator: Carole CHIRICA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Follow-up telephone call after one month; 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.; Other Names: A follow-up telephone call after one month for the subgroup of patients who had a negative biomarker result without an initial CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of protocol deviations	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	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	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Nicolas SEGOND, MD PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Estimated): November 5, 2026
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: October 29, 2026
• First Submitted That Met QC Criteria: November 5, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 5, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; GFAP; Mild Traumatic Brain Injury (mTBI); UCH-L1; Brain CT Scan
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion
• Other Study ID Numbers: 38RC26.0261; IDRCB : 2026-A01713-48 (Other Identifier: CPP Est III (French Ethics Committees))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Time Frame

At the time of publication

IPD Sharing Access Criteria

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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No