An observational study in Mild Traumatic Brain Injury (mTBI) and Biomarkers, sponsored by University Hospital, Grenoble. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University Hospital, Grenoble · Observational
Among 27 studies in Brain Concussion with a site in France — 8 open to participants now, 9 under way, none of them phase 3. Brain Concussion · France.
Among the 27 studies in Brain Concussion with a site in France, this one is the 5th largest by planned enrollment of the 15 observational ones that give a count, is one of 2 that started in 2026, is one of 15 observational ones, and was the 27th registered.
639 studies on the registry are indexed under Brain Concussion; 165 are open to participants now.
Browse Brain Concussion studies →8 of the 27 studies in Brain Concussion with a site in France are open now. Recruiting first, the newest first:
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape · Sites in France
Ages 16+ · Men only · Healthy volunteers
Hospices Civils de Lyon · Sites in France
Ages 18–70 · Healthy volunteers
Assistance Publique Hopitaux De Marseille · Sites in France
Ages 18–90 · Healthy volunteers
Sys2Diag · Sites in France
Ages 19–20 · Men only · Healthy volunteers
University Hospital, Bordeaux · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 112 Brain Concussion studies recruiting now, 33 (29%) set no upper age limit and 72 (64%) stop at 75 or younger; 24 take children under 18; 38 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 800 is above the median of 149 across 167 observational studies indexed under Brain Concussion.
Median enrollment 85 across the 12 interventional studies, 560 across the 15 observational. Of the 14 that completed or were terminated, 1 (7%) have results posted.
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1 of 27 have an industry lead sponsor. The 10 most frequent:
University Hospital, Grenoble is the lead sponsor of 838 studies on the registry; 208 are open to participants now.
University Hospital, Grenoble has 3 studies filed under Brain Concussion — fewer than ten, so there is no comparison to draw.
4 of the studies in Brain Concussion with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07507253Sys2DiagPilot Study on the Correlation Between Accelerations Experienced | 2027-01-21 |
| NCT07931066University Hospital, GrenobleThe Use of GFAP and UCH-L1 Biomarkers in Clinical Practice for the Management of Mild Traumatic Brain Injury | 2027-03-05 |
| NCT05719844University Hospital, Clermont-FerrandInterest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players | 2027-03-09 |
| NCT06244472Hospices Civils de LyonA New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging | 2027-08 |
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Among the 27 studies in Brain Concussion with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: A follow-up telephone call after one month for the subgroup of patients who had a negative biomarker result without an initial CT scan
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
Time frame: 1 month
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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 1 month
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: At the time of publication
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
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 72 non-industry observational studies under Brain Concussion, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 188. This study's planned 4 months is below that.
Counting every sponsor, half of 94 studies reached it within 35 months; a quarter within 16 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble →