NCT07835919

Brief Summary

KIDS-STAT is a prospective study evaluating whether a rapid blood test measuring the brain injury biomarkers GFAP and UCH-L1 using the i-STAT Alinity system can help identify children with mild traumatic brain injury who do not have acute traumatic findings on head CT. The study will include children younger than 18 years who present within 24 hours of a suspected mild traumatic brain injury. Blood will be collected during the emergency department visit and tested using the i-STAT TBI cartridge. The test results will be used for research purposes only and will not be used to make clinical care decisions. The primary objective is to determine how reliably a negative i-STAT TBI result identifies children without traumatic findings on head CT. Secondary analyses will evaluate test performance across age groups and in relation to clinical characteristics and outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
64mo left

Started Oct 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2031

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

5 years

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Mild Traumatic Brain InjuryPediatric Traumatic Brain InjuryHead Trauma

Keywords

BiomarkersBrain imagingHead CT scanPediatric TBIDiagnostic Accuracy

Outcome Measures

Primary Outcomes (2)

  • Negative Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT

    Negative predictive value (NPV) of a negative i-STAT Alinity TBI whole-blood test, defined as GFAP \<65 pg/mL and UCH-L1 \<360 pg/mL, for the absence of acute traumatic findings on head CT in children with mild traumatic brain injury.

    During the index emergency department visit, within 24 hours of injury

  • Sensitivity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT

    Sensitivity of the i-STAT Alinity TBI whole-blood test for detecting acute traumatic findings on head CT in children with mild traumatic brain injury

    During the index emergency department visit, within 24 hours of injury

Secondary Outcomes (11)

  • Specificity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT

    During the index emergency department visit, within 24 hours of injury

  • Positive Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT

    During the index emergency department visit, within 24 hours of injury

  • Positive and Negative Likelihood Ratios of the i-STAT Alinity TBI Test

    During the index emergency department visit, within 24 hours of injury

  • Diagnostic Performance of the i-STAT Alinity TBI Test for Clinically Important Traumatic Brain Injury

    During the index emergency department visit and through 90 days

  • Diagnostic Performance of the i-STAT Alinity TBI Test for Neurosurgically Managed Lesions

    During the index emergency department visit and through 90 days

  • +6 more secondary outcomes

Study Arms (1)

i-STAT TBI Biomarker Testing

EXPERIMENTAL

Participants will undergo blood-based biomarker testing using the i-STAT TBI Cartridge with the i-STAT Alinity System. GFAP and UCH-L1 values will be collected for research purposes and compared with head CT findings obtained as part of standard clinical care. Biomarker results will not be used to guide clinical decision-making.

Device: i-STAT TBI Cartridge with the i-STAT Alinity System

Interventions

i-STAT TBI Cartridge with the i-STAT Alinity SystemDEVICE

A point-of-care blood test measuring glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1). A blood sample will be analyzed using the i-STAT Alinity system, and biomarker values will be recorded for research analysis.

Also known as: i-STAT TBI Test
i-STAT TBI Biomarker Testing

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children younger than 18 years of age
  • Presentation to the emergency department with suspected non-penetrating traumatic brain injury resulting from an external force
  • Glasgow Coma Scale (GCS) score of 13-15 at the time of informed consent
  • Non-contrast head CT performed within 24 hours of injury as part of clinical care
  • Blood sampling within 24 hours of injury

You may not qualify if:

  • Penetrating brain injury
  • Presentation more than 24 hours after injury or inability to determine the time of injury
  • Current participation in a clinical trial involving an investigational therapy for traumatic brain injury
  • Treatment with an investigational product within the previous 30 days
  • Unsurvivable physical trauma with death expected within 24 hours of enrollment
  • In the custody of law enforcement or a ward of the state or federal government
  • Pre-existing neurodegenerative or neurological disease that could interfere with study assessment, including Alzheimer's disease, Parkinson's disease, multiple sclerosis, or brain tumor
  • Psychiatric disorder that, in the investigator's judgment, could interfere with the participant's or legal representative's ability to understand or comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain ConcussionCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Andrew Reisner, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meena Verma, MD

CONTACT

3102663220Meena.Verma@choa.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Neuro Trauma and Concussion

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

January 1, 2032

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

The research team will share deidentified individual participant data underlying the results reported in publications.

Time Frame
Deidentified data may be made available following approval of a data request and execution of an appropriate Data Use Agreement. The duration of access will be defined for each approved request, and permissions will be reviewed and renewed periodically.
Access Criteria
Investigators with appropriate Institutional Review Board approval may submit data access requests to the study investigators. Approved requests will require execution of an appropriate Data Use Agreement.