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Brain Injury Traumatic Mildpaeds_mTBI_BioNCT07397091

Using Routine Inflammatory and Metabolic Blood Tests (Bedside Included) to Predict Brain Injury in Children After Minor Head Trauma

An observational study of Brain Injury Traumatic Mild, run by Iuliu Hatieganu University of Medicine and Pharmacy at 7 sites in Romania.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Brain Injury Traumatic Mild
How many people
800 participants
Where
7 sitesRomania
Study dates
20 Apr 2026to 20 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Paediatric patients being admitted to ED for minor traumatic brain injuries, who are undergoing a head CT scan and routine blood tests.

Who may be able to join

  • Patients aged 0 to 18 years old presenting to the ED with mild traumatic brain injury (with or without cervical injury):
  • Mild TBI will be defined as GCS 14-15 or A (AVPU) upon admission
  • Patients underwent head CT
  • Routine blood biomarkers have been collected (complete blood count - CBC, biochemistry and/or (arterial) venos blood gases - (A)VBG).

Who cannot join

  • Patients with moderate (GCS 13-9 or V) or severe (GCS 8-3 or P,U) head trauma
  • Patients with associated trauma (limb/rib/pelvic fractures, organ injuries).

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eugenia M Lupan-Muresan, MD, PhD contact

+40748451098

muresan.eugenia@umfcluj.ro

Daniela M Mitrofan, MD contact

+40 751 110 065

danamitro@yahoo.com

7 sites in 1 country

Romania7 sites

  • Spitalul Clinic Judetean de Urgenta

    Arad

    Monica I Puticiu, MD, PhD, Lecturer, +40744 519 805, puticiumonica@yahoo.com

    Monica I Puticiu, MD, PhD, Lecturer

  • Spitalul Judetean de Urgenta

    Baia Mare

    Dacian Juca, MD, dacij@yahoo.co.uk

    Lavinia D Ciurdas, MD

  • Spitalul Clinic Judetean de Urgenta

    Bistriţa

    Julia Magyar, MD, +40746 835 556, juliamagyar@yahoo.com

    Julia Magyar, MD

  • Spitalul Judetean de Urgenta MAVROMATI

    Botoșani

    Ramona I Ciornea, RN, +40740 499 490, rciornea44@gmail.com

    Ramona I Ciornea, RN

  • Spitalul Clinic de Urgenta penru Copii

    Brasov

    Octavian Dumitras, MD, +40746 603 788, odumitras@yahoo.com

    Octavian Dumitras, MD

  • Spitalul Clinic de Urgenta pentru Copii

    Cluj-Napoca

    Daniela M Mitrofan, MD, PhD, +40 751 110 065, danamitro@yahoo.com

    Daniela M Mitrofan, MD

  • Spitalul Clinic Judetean de Urgenta

    Craiova

    Luciana Rotaru, MD, PhD, Professor, +40751 110 065, lucianarotaru@yahoo.com

    Luciana Rotaru, MD, PhD, Professor

Other trials in Romania

About this study

Official title: ROUTINE INFLAMMATORY AND METABOLIC BIOMARKERS. Can They Predict a Positive Head CT in Paediatric Minor Traumatic Brain Injury?

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.

Read the detailed description

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.

  1. 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.
  2. Glucose as a Modifiable Risk Factor Metabolic distress, specifically hyperglycemia, is a critical factor in the acute phase of TBI.

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.

Keywords
routine biomarkers, traumatic brain injury, inflammatory, metabolic
Medical subject headings
Brain Concussion, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07397091
Study groupRoleWhat they receive
Patients aged 0 to 18, mild TBI (GCS 14-15 or A on AVPU)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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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
    1. C Reactive Protein
    2. Glucose
    3. (A)VBG - pH, lactate, base deficit, anion gap, bicarb

    Measured: Upon ED admission for mTBI

Secondary outcomes (1)

  1. 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.

    Measured: Upon ED admission for mTBI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion20 Jun 2026 (estimated)
  4. Study completion20 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397091
Sponsor's protocol ID
DEP23/21.01.2026
Acronym
paeds_mTBI_Bio
Status last verified
Jan 2026
First submitted
30 Jan 2026
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Alexiou GA, Sotiropoulos A, Lianos GD, Zigouris A, Metaxas D, Nasios A, Michos E, Mitsis M, Pachatouridis D, Voulgaris S. Blood Glucose Levels May Aid the Decision for CT Scan in Minor Head Trauma. Dis Markers. 2019 Apr 9;2019:1065254. doi: 10.1155/2019/1065254. eCollection 2019.

    PubMed 31093304

  • Alexiou GA, Lianos G, Fotakopoulos G, Michos E, Pachatouridis D, Voulgaris S. Admission glucose and coagulopathy occurrence in patients with traumatic brain injury. Brain Inj. 2014;28(4):438-41. doi: 10.3109/02699052.2014.888769. Epub 2014 Feb 24.

    PubMed 24564221

  • Shi J, Dong B, Mao Y, Guan W, Cao J, Zhu R, Wang S. Review: Traumatic brain injury and hyperglycemia, a potentially modifiable risk factor. Oncotarget. 2016 Oct 25;7(43):71052-71061. doi: 10.18632/oncotarget.11958.

    PubMed 27626493

  • Parenrengi MA, Suryaningtyas W, Dariansyah AD, Utomo B, Taryana GO, Kusumo C, Brilliantika SP. Utility of systemic immune-inflammation index, neutrophil-to-lymphocyte ratio, and platelet-to-lymphocyte ratio as a predictive biomarker in pediatric traumatic brain injury. Surg Neurol Int. 2024 Dec 6;15:456. doi: 10.25259/SNI_900_2024. eCollection 2024.

    PubMed 39777169

  • Melo JRT, Masini MHH, de Oliveira JG, Veiga JCE. Performance of the neutrophil-lymphocyte ratio as a predictor of severity and mortality in children and adolescents with traumatic brain injury. Childs Nerv Syst. 2024 Dec;40(12):4251-4257. doi: 10.1007/s00381-024-06556-9. Epub 2024 Jul 30.

    PubMed 39080015

  • Mukherjee S, Sivakumar G, Goodden JR, Tyagi AK, Chumas PD. Prognostic value of leukocytosis in pediatric traumatic brain injury. J Neurosurg Pediatr. 2020 Dec 25;27(3):335-345. doi: 10.3171/2020.7.PEDS19627. Print 2021 Mar 1.

    PubMed 33361484

  • Kimball R, Shachar E, Eyerly-Webb S, Patel DM, Spader H. Using the neutrophil-to-lymphocyte ratio to predict outcomes in pediatric patients with traumatic brain injury. Clin Neurol Neurosurg. 2020 Jun;193:105772. doi: 10.1016/j.clineuro.2020.105772. Epub 2020 Mar 3.

    PubMed 32155528

  • Siempis T, Georgalis PA, Lianos G, Kafritsas G, Metaxas D, Alexiou ES, Zika J, Sotiropoulos A, Alexiou GA, Voulgaris S. Blood Biomarkers for Prediction of Positive CT Findings in Mild Traumatic Brain Injury in Paediatric Population. J Integr Neurosci. 2023 Jul 7;22(4):91. doi: 10.31083/j.jin2204091.

    PubMed 37519178

  • Oris C, Pereira B, Durif J, Simon-Pimmel J, Castellani C, Manzano S, Sapin V, Bouvier D. The Biomarker S100B and Mild Traumatic Brain Injury: A Meta-analysis. Pediatrics. 2018 Jun;141(6):e20180037. doi: 10.1542/peds.2018-0037. Epub 2018 May 1.

    PubMed 29716980

  • Babcock L, Byczkowski T, Mookerjee S, Bazarian JJ. Ability of S100B to predict severity and cranial CT results in children with TBI. Brain Inj. 2012;26(11):1372-80. doi: 10.3109/02699052.2012.694565. Epub 2012 Jun 22.

    PubMed 22725661

  • Papa L, Brophy GM, Welch RD, Lewis LM, Braga CF, Tan CN, Ameli NJ, Lopez MA, Haeussler CA, Mendez Giordano DI, Silvestri S, Giordano P, Weber KD, Hill-Pryor C, Hack DC. Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury. JAMA Neurol. 2016 May 1;73(5):551-60. doi: 10.1001/jamaneurol.2016.0039.

    PubMed 27018834

  • Wang KK, Yang Z, Zhu T, Shi Y, Rubenstein R, Tyndall JA, Manley GT. An update on diagnostic and prognostic biomarkers for traumatic brain injury. Expert Rev Mol Diagn. 2018 Feb;18(2):165-180. doi: 10.1080/14737159.2018.1428089. Epub 2018 Jan 23.

    PubMed 29338452

  • Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Buki A, Chen JY, Christenson RH, Hack D, Huff JS, Johar S, Jordan JD, Leidel BA, Lindner T, Ludington E, Okonkwo DO, Ornato J, Peacock WF, Schmidt K, Tyndall JA, Vossough A, Jagoda AS. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018 Sep;17(9):782-789. doi: 10.1016/S1474-4422(18)30231-X. Epub 2018 Jul 24.

    PubMed 30054151

  • Marincowitz C, Lecky FE, Townend W, Borakati A, Fabbri A, Sheldon TA. The Risk of Deterioration in GCS13-15 Patients with Traumatic Brain Injury Identified by Computed Tomography Imaging: A Systematic Review and Meta-Analysis. J Neurotrauma. 2018 Mar 1;35(5):703-718. doi: 10.1089/neu.2017.5259. Epub 2018 Jan 11.

    PubMed 29324173

  • Sheppard JP, Nguyen T, Alkhalid Y, Beckett JS, Salamon N, Yang I. Risk of Brain Tumor Induction from Pediatric Head CT Procedures: A Systematic Literature Review. Brain Tumor Res Treat. 2018 Apr;6(1):1-7. doi: 10.14791/btrt.2018.6.e4.

    PubMed 29717567

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injury Traumatic Mild, run by Iuliu Hatieganu University of Medicine and Pharmacy at 7 sites in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eugenia M Lupan-Muresan, MD, PhD (+40748451098, muresan.eugenia@umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Routine Biomarkers (time frame: Upon ED admission for mTBI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397091, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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