An observational study in Brain Injury Traumatic Mild, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Not yet recruiting at 7 sites in Romania. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Observational
Traumatic brain injury (TBI) poses significant strains on the paediatric population, for which the possible side effects of diagnostic imagistics could induce life-altering conditions. Routine inflammatory and metabolic biomarkers (complete blood count, C reactive protein, glucose) are frequently sampled in the paediatric patients admited within emergency departments, including the low-resource settings. This study aims to retrospectively document whether such routine blood biomarkers could predict a positive head CT scan and subsequently contribute to a prediction score, ment to enable more accurate decision on which minor TBI paediatric patients should be submitted to diagnotic imagistics.
Epidemiology and Clinical Context Traumatic brain injury (TBI) is a significant global health concern, with an estimated paediatric global annual incidence of 226.4 cases per 100,000 children. The vast majority of these cases are categorized as non-severe, as up to 95% of head injuries in children are classified as minor or mild (mTBI). Nevertheless, approximately one-third of paediatric patients experience persistent symptoms lasting beyond one month.
The current diagnostic gold standard remains non-contrast head Computed Tomography (CT). However, CT utilization carries significant associated risks, including exposure to ionizing radiation, high institutional costs, and the frequent necessity for procedural sedation. To mitigate these risks, clinical decision rules such as PECARN, CATCH, and CHALICE were developed to identify children at high risk for intracranial lesions. Despite these tools, most CT scans are still performed in cases of mTBI where the diagnostic yield is remarkably low.
As such, additional aiding tools have been investigated for refining the clinical decision rules regarding the paediatric mTBI patients in need of a CT scan.
Brain-Specific Biomarkers (GFAP, UCH-L1, S100B) In 2018, the US FDA authorized the first biomarkers (GFAP and UCH-L1) for predicting the necessity of CT scans in patients with minor TBI, supported by the ALERT-TBI trial. These markers serve as critical tools for both diagnosis and prognosis in neurotrauma.
GFAP (Glial Fibrillary Acidic Protein) is an astroglial protein that can predict positive CT findings in children with a sensitivity of 94% and a specificity of 47%. Its high sensitivity makes it an ideal "rule-out" marker.
UCH-L1 (Ubiquitin C-terminal Hydrolase L1) is a neuronal marker released into the bloodstream following axonal injury.
While extensively studied, S100B has shown limitations in paediatric emergency care. Research demonstrated it could not accurately predict positive CT findings in children with a normal GCS. Furthermore, its specificity is hindered by age-dependent baseline levels.
Routine Hematological and Metabolic Markers Beyond brain-specific proteins, routine complete blood count (CBC) parameters and metabolic markers provide an immediate, cost-effective snapshot of the injury's systemic impact, additionally to being easily accessible even in low-resource environments.
Inflammatory Indexes (NLR, Delta NLR, SII) Paediatric TBI patients with intracranial lesions on imaging demonstrate a significantly higher absolute neutrophil count.
Significant differences in the Neutrophil-to-Lymphocyte Ratio (NLR) are observed at 24 and 48 hours post-injury. Longitudinal changes (Delta NLR) are associated with poorer clinical outcomes in children.
The Systemic Immune-Inflammation Index (SII) (Neutrophils × Platelets / Lymphocytes) is increasingly used to monitor the secondary inflammatory cascade.
Admission glucose levels are a potentially modifiable risk factor in TBI; elevated glucose is closely linked to the severity of the primary injury and the occurrence of coagulopathy in TBI patients, further complicating the clinical trajectory. Elevated blood glucose levels may aid clinicians in the decision-making process for ordering CT scans in cases of minor head trauma.
Conclusion The integration of specialized biomarkers like GFAP and UCH-L1 offers high sensitivity for ruling out acute pathology, yet their availability remains limited in the setting of emergency care. As such, routine biomakers, such as glucose levels, CBC panel and its derived inflammatory indexes, could provide relevant prognostic data in a more cost-effective approach for the triage and monitoring of emergency department paediatric mTBI, whilst limiting the radiation exposure of paediatric patients.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 800 is above the median of 149 across 166 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →Iuliu Hatieganu University of Medicine and Pharmacy is the lead sponsor of 56 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Paediatric patients being admitted to ED for minor traumatic brain injuries, who are undergoing a head CT scan and routine blood tests.
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.
Patients aged 0 to 18 years old presenting to the ED with mild traumatic brain injury (with or without cervical injury):
Exclusion Criteria:
Patients aged 0 to 18 years old presenting to the ED with mild traumatic brain injury (with or without cervical injury): 1. Mild TBI will be defined as GCS 14-15 or A (AVPU) upon admission 2. Patients underwent head CT 3. Routine blood biomarkers have been collected (complete blood count - CBC, biochemistry and/or (arterial) venos blood gases - (A)VBG).
Routine Biomarkers
1. CBC, the following items being mandatory: * WBC (white blood cells) and its subpopulations (NEU, LYM, MON) * NLR (neutrophiles-to-lymphocytes ratio) * PLR (platelets-to-lymphocyes ratio) * MLR (monocytes-to-lymphocytes ratio) * SII (systemic immune inflammation) index = NEU x PLT/ LYM * SIRI (systemic inflammatory response index) = NEU x MON/ LYM 2. C Reactive Protein 3. Glucose 4. (A)VBG - pH, lactate, base deficit, anion gap, bicarb
Time frame: Upon ED admission for mTBI
Epidemiological Data
Additionally, epidemological data will be collected (age, gender, trauma mechanism, associated lessions, risk factors for TBI classification, physical examination, need of procedural sedation, seniority of treating physician, disposition), alongside the results of the head (and cervical) CT scan.
Time frame: Upon ED admission for mTBI
TBI Registry
A TBI registry will be also filled in, registering all TBI patients who do not meet the study inclusion criteria (mTBI without CT scan, moderate and severe TBI). For these patients, the collected data are the following: * patient ID * gender, age * GCS upon admission * TBI severity (as mentioned in the final ED diagnosis) * seniority of treating physician
Time frame: Upon ED admission for mTBI
Plan to share: Undecided
Start is estimated for Apr 2026; primary completion for Jun 2026, 2 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Iuliu Hatieganu University of Medicine and Pharmacy