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

Conditions

• Pediatric Traumatic Brain Injury

Eligibility Criteria

Sex

ALL

Age

N/A - 17 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 14, 2025

Status verified

Apr 2025

Primary completion

May 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

330 participants (estimated)

Arms

• Arm: Group 1 - Traumatic Brain Injury With Positive Head Computed Tomography Findings
  Group 1 will be 110 participants who had a traumatic brain injury (TBI) with positive head computed tomography (HCT).
• Arm: Group 2 - Traumatic Brain Injury With Negative Head Computed Tomography Findings
  Group 2 will be 110 participants with a known traumatic brain injury (TBI), but a negative head computed tomography (HCT).
• Arm: Group 3 - All Other Trauma Participants With No History of Head Injury
  Group 3 will be 110 participants being treated for a traumatic injury with no history of head injury.

Primary Outcome Measure

Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups [ Time Frame: Within 24 hours of injury ]

Central Contacts

• Megan McChesney, BSN, RN, CPN
  531-375-3835
  [email protected]

Locations (1)

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