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

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 design

Treatments tested in this trial

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

Treatment groups

330 Participants
are divided into 3 treatment groups

Sponsors and collaborators