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

NCT07397091 | Not Yet Recruiting

• 1 other identifier: DEP23/21.01.2026
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Brain Injury Traumatic Mild

Keywords

routine biomarkers; traumatic brain injury; inflammatory; metabolic

Outcome Measures

Primary Outcomes (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 2. C Reactive Protein 3. Glucose 4. (A)VBG - pH, lactate, base deficit, anion gap, bicarb

  Upon ED admission for mTBI

Secondary Outcomes (1)

• Epidemiological Data

  Upon ED admission for mTBI

Other Outcomes (1)

• TBI Registry

  Upon ED admission for mTBI

Study Arms (1)

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).

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead
• Children's Emergency Clinical Hospital Cluj-Napoca: collaborator

Study Sites (7)

Spitalul Clinic Judetean de Urgenta

Arad, Romania

Location

Spitalul Judetean de Urgenta

Baia Mare, Romania

Location

Spitalul Clinic Judetean de Urgenta

Bistriţa, Romania

Location

Spitalul Judetean de Urgenta MAVROMATI

Botoșani, Romania

Location

Spitalul Clinic de Urgenta penru Copii

Brasov, Romania

Location

Spitalul Clinic de Urgenta pentru Copii

Cluj-Napoca, Romania

Location

Spitalul Clinic Judetean de Urgenta

Craiova, Romania

Location

Related Publications (18)

• 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.

  PMID: 31093304 BACKGROUND

• 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.

  PMID: 24564221 BACKGROUND

• 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.

  PMID: 27626493 BACKGROUND

• 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.

  PMID: 39777169 BACKGROUND

• 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.

  PMID: 39080015 BACKGROUND

• 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.

  PMID: 33361484 BACKGROUND

• 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.

  PMID: 32155528 BACKGROUND

• 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.

  PMID: 37519178 BACKGROUND

• 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.

  PMID: 29716980 BACKGROUND

• 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.

  PMID: 22725661 BACKGROUND

• 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.

  PMID: 27018834 BACKGROUND

• 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.

  PMID: 29338452 BACKGROUND

• 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.

  PMID: 30054151 BACKGROUND

• 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.

  PMID: 29324173 BACKGROUND

• 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.

  PMID: 29717567 BACKGROUND

• Eisenberg MA, Andrea J, Meehan W, Mannix R. Time interval between concussions and symptom duration. Pediatrics. 2013 Jul;132(1):8-17. doi: 10.1542/peds.2013-0432. Epub 2013 Jun 10.

  PMID: 23753087 BACKGROUND

• Babl FE, Borland ML, Phillips N, Kochar A, Dalton S, McCaskill M, Cheek JA, Gilhotra Y, Furyk J, Neutze J, Lyttle MD, Bressan S, Donath S, Molesworth C, Jachno K, Ward B, Williams A, Baylis A, Crowe L, Oakley E, Dalziel SR; Paediatric Research in Emergency Departments International Collaborative (PREDICT). Accuracy of PECARN, CATCH, and CHALICE head injury decision rules in children: a prospective cohort study. Lancet. 2017 Jun 17;389(10087):2393-2402. doi: 10.1016/S0140-6736(17)30555-X. Epub 2017 Apr 11.

  PMID: 28410792 BACKGROUND

• Baticulon RE, Sy JJ, Haizel-Cobbina J, Du L, Figueredo L, Hounjet C, Mitchell R, Shlobin NA, Dewan MC. Global Epidemiology of Pediatric Traumatic Brain Injury: Systematic Review and Meta-Analysis. Neurosurgery. 2025 Dec 12. doi: 10.1227/neu.0000000000003875. Online ahead of print.

  PMID: 41384742 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Eugenia M Lupan-Muresan, MD, PhD

  Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

  PRINCIPAL INVESTIGATOR

• Daniela M Mitrofan, MD

  Children's Emergency County Hospital Cluj-Napoca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenia M Lupan-Muresan, MD, PhD

CONTACT

+40748451098; muresan.eugenia@umfcluj.ro

Daniela M Mitrofan, MD

CONTACT

+40 751 110 065; danamitro@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 9, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-01

Locations

RO (7)