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

March 25, 2026 updated by: Eugenia-Maria Lupan-Muresan, Iuliu Hatieganu University of Medicine and Pharmacy

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Romania
      • Arad, Romania
        • Spitalul Clinic Județean de Urgență
        • Contact:
        • Principal Investigator:
          • Monica I Puticiu, MD, PhD, Lecturer
      • Baia Mare, Romania
        • Spitalul Judetean de Urgenta
        • Contact:
        • Principal Investigator:
          • Lavinia D Ciurdas, MD
      • Bistriţa, Romania
        • Spitalul Clinic Județean de Urgență
        • Contact:
        • Principal Investigator:
          • Julia Magyar, MD
      • Botoșani, Romania
        • Spitalul Judetean de Urgenta MAVROMATI
        • Contact:
        • Principal Investigator:
          • Ramona I Ciornea, RN
      • Brasov, Romania
        • Spitalul Clinic de Urgenta penru Copii
        • Contact:
        • Principal Investigator:
          • Octavian Dumitras, MD
      • Cluj-Napoca, Romania
        • Spitalul Clinic de Urgenta pentru Copii
        • Contact:
        • Principal Investigator:
          • Daniela M Mitrofan, MD
      • Craiova, Romania
        • Spitalul Clinic Județean de Urgență
        • Contact:
        • Principal Investigator:
          • Luciana Rotaru, MD, PhD, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion 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).

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Routine Biomarkers
Time Frame: Upon ED admission for mTBI

  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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological Data
Time Frame: Upon ED admission for mTBI
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.
Upon ED admission for mTBI

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBI Registry
Time Frame: Upon ED admission for mTBI

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
Upon ED admission for mTBI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

Children's Emergency Clinical Hospital Cluj-Napoca

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

June 20, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP23/21.01.2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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