An observational study in Traumatic Brain Injury, sponsored by Centre Hospitalier Princesse Grace. Recruiting at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Centre Hospitalier Princesse Grace · Observational
The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question :
Participants will do the exams planed in routine care and :
Main study
The main study includes subjects presenting to the emergency department within 12 hours of mild traumatic brain injury with an intermediate risk of clinical worsening or intracranial lesions.
The participants have at least one of the following characteristics, as defined in the French recommendations
The study includes clinical sites in France and Monaco. Participants have a blood sample and a brain scan as part of the care. The participation of subjects in the study will not influence their treatment.
Ancillary study The ancillary study uses qualitative research methodology to assess acceptance by physicians and patients of a biological test rather than a CT scan to exclude intracranial complication after mild traumatic brain injury.
The study will takes place in the emergency department of the Nice University Hospital Center (CHU of Nice). It will include 30 subjects: 15 subjects presenting to the emergency room for mild traumatic brain injury and included in the main protocol and 15 prescribing emergency physicians.
The participation of subjects in the study will not influence their treatment.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Centre Hospitalier Princesse Grace is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult subjects consulting in the emergency department within 12 hours following a mild traumatic brain injury at risk of complications meeting the inclusion and exclusion criteria listed in the protocol.
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.
Traumatic brain injury defined by
One of the following 4 criteria:
Exclusion Criteria:
Subjects for which a scan would be carried out systematically, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study
Other: UCH-L1 GFAP
measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI
Percentage of intracranial lesion excluded by UCH-L1 and GFAP combined, versus the CT scan, within the first 12 hours following a MTBI
Time frame: during the first 12 hours
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
Percentage of intracranial bleeding excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI
Time frame: during the first 12 hours
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
Percentage of intracranial lesion excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI .
Time frame: during the first 12 hours with a focus every 3 hours
Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b)
Percentage of intracranial complication identified by UCH-L1 and GFAP, alone or in combination, versus PS100b within the first 12 hours following a MTBI .
Time frame: during the first 12 hours with a focus every 3 hours
Predicted impact of using UCH-L1 and GFAP combined
Variation of resource consumption by the use of UCH-L1 and GFAP
Time frame: day 7
Performance of UCHL-1 and GFAP alone or combined to predict complications
Percentage of complications avoided by the use of UCH-L1 and GFAP, alone or combined.
Time frame: during the first 7 days
ancillary outcome
Acceptability by a semi-directed interview of a new strategy integrating the use of biomarkers for the management of MTBI by patients and investigators
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2025, 19 months after the start.
Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 19 months is below that.
Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Centre Hospitalier Princesse Grace