Validating a Blood Test for the Detection of Traumatic Brain Injury in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorUniversity of Nebraska

About this trial

The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). The participant population is pediatric patients, ages 0 to less than 18 years old with a possible TBI or trauma-related injury who have blood drawn per standard of care in the emergency department. Blood samples will be analyzed using the i-STAT TBI cartridge (Abbott Laboratories, Abbott Park, IL, USA) by the Emergency Department charge nurse within one hour of collection of the blood sample. Clinical outcomes will be assessed via telephone interview with a parent at 3 and 6 months for all surviving TBI patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

0-17 years of age

Presentation of non-penetrating trauma

Blood draw within 24 hours of injury

For TBI group: head CT or MRI obtained

Disqualifiers

Presentation to Children's Nebraska after 24 hours of injury

18 years of age or older

Trial population

Patients under the age of 18 (0-17) who present to the emergency room in the setting of non-penetrating trauma and blood draw within 24 hours of injury will be screened. All participants who present as a trauma activation will automatically have blood drawn as part of the trauma protocol. Participants with head trauma who do not present as a trauma activation (i.e. arrived via private auto) will have labs drawn at the discretion of the treating physician.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers

    Diagnostic test

    All groups will have blood drawn per standard of care. Blood samples will be analyzed using Traumatic Brain Injury (TBI) cartridges for iSTAT Alinity device.

Treatment groups

330 Participants
are divided into 3 treatment groups
Group A: Group 1 - Traumatic Brain Injury With Positive Head Computed Tomography Findings1 intervention
Group B: Group 2 - Traumatic Brain Injury With Negative Head Computed Tomography Findings1 intervention
Group C: Group 3 - All Other Trauma Participants With No History of Head Injury1 intervention

Trial outcomes

Primary outcomes

1

Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups

Serum Glial Fibrillary Acidic Protein (GFAP) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.

Time frame
Within 24 hours of injury
2

Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups

Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.

Time frame
Within 24 hours of injury
3

Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Between Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan

Serum Glial Fibrillary Acidic Protein (GFAP) measured with a i-STAT TBI cartridge within 24 hours of traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with TBI and an abnormal head computed tomography (CT) scan.

Time frame
Within 24 hours of injury
4

Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, in Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan

Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with (TBI) and an abnormal head computed tomography (CT) scan.

Time frame
Within 24 hours of injury

Secondary outcomes

Other outcomes

Sponsors and contacts

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