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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorIuliu Hatieganu University of Medicine and Pharmacy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 population

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

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

800 Participants
are grouped into 1 trial group
Group A: Patients aged 0 to 18, mild TBI (GCS 14-15 or A on AVPU)

Trial outcomes

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

Time frame
Upon ED admission for mTBI

Secondary outcomes

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.

Time frame
Upon ED admission for mTBI

Other outcomes

1

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

Sponsors and contacts

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Iuliu Hatieganu University of Medicine and Pharmacy

Lead sponsor

Children's Emergency Clinical Hospital Cluj-Napoca

Collaborator

This trial is not recruiting at the moment. You can still explore other options: