Mild Traumatic Brain InjuryKIDS-STATNCT07835919
Kids Injury Detection Study Using the i-STAT
A study testing i-STAT TBI Cartridge with the i-STAT Alinity System in people with Mild Traumatic Brain Injury and Pediatric Traumatic Brain Injury, run by Children's Healthcare of Atlanta.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury, Head Trauma
- What is being tested?
- i-STAT TBI Cartridge with the i-STAT Alinity System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Kids Injury Detection Study (KIDS-STAT) Using the i-STAT: Point of Care TBI Biomarker Testing
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.
Read the detailed description
The Kids Injury Detection Study using the i-STAT (KIDS-STAT) aims to evaluate whether a rapid blood-based test measuring glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) can accurately identify children with mild traumatic brain injury (mTBI) who do not have acute traumatic findings on head CT. The study will also evaluate test performance across pediatric age groups, assess performance for clinically important TBI and neurosurgically managed lesions, compare biomarker results with PECARN risk categories, and examine whether age, mechanism of injury, and time from injury influence biomarker performance. Clinical outcomes, including return emergency department visits, hospital readmission, delayed neurosurgical intervention, repeat or delayed neuroimaging, and functional status, will also be characterized through 90 days.
The study will enroll children younger than 18 years presenting to the emergency department at Children's Healthcare of Atlanta with suspected non-penetrating mild traumatic brain injury, a Glasgow Coma Scale score of 13-15, and presentation within 24 hours of injury. Participants must have undergone non-contrast head CT as part of their clinical care and have blood collected within 24 hours of injury. Children with penetrating brain injury, presentation outside the 24-hour injury window, or an indeterminate time of injury will not be enrolled.
Participants will undergo a one-time research blood draw during the emergency department visit. Blood will be tested using the i-STAT Alinity TBI system to measure GFAP and UCH-L1, and the biomarker results will be recorded for research analysis. Head CT imaging will be performed as part of standard clinical care, and imaging findings will serve as the reference standard for evaluating biomarker performance. i-STAT results will not be used to guide clinical decision-making or alter patient care.
- Being tested
- i-STAT TBI Cartridge with the i-STAT Alinity System
- Keywords
- Biomarkers, Brain imaging, Head CT scan, Pediatric TBI, Diagnostic Accuracy
- Medical subject headings
- Brain Concussion, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-STAT TBI Cartridge with the i-STAT Alinity SystemDevice
Also called i-STAT TBI Test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: i-STAT TBI Cartridge with the i-STAT Alinity System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Specificity of the i-STAT Alinity TBI whole-blood test for identifying the absence of acute traumatic findings on head CT, evaluated overall and within prespecified age strata (<5, 5-<12, and 12-<18 years).
Measured: 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
Positive predictive value (PPV) of the i-STAT Alinity TBI whole-blood test for acute traumatic findings on head CT, evaluated overall and within prespecified age strata (<5, 5-<12, and 12-<18 years).
Measured: During the index emergency department visit, within 24 hours of injury
Positive and Negative Likelihood Ratios of the i-STAT Alinity TBI Test
Positive and negative likelihood ratios of the i-STAT Alinity TBI whole-blood test for acute traumatic findings on head CT, evaluated overall and within prespecified age strata (<5, 5-<12, and 12-<18 years).
Measured: 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
Diagnostic performance of the i-STAT Alinity TBI whole-blood test for identifying clinically important traumatic brain injury (ciTBI).
Measured: During the index emergency department visit and through 90 days
Diagnostic Performance of the i-STAT Alinity TBI Test for Neurosurgically Managed Lesions
Diagnostic performance of the i-STAT Alinity TBI whole-blood test for identifying traumatic intracranial lesions requiring neurosurgical management.
Measured: During the index emergency department visit and through 90 days
Association Between i-STAT TBI Test Performance and PECARN Risk Category
Performance of the i-STAT Alinity TBI test will be evaluated in relation to the applicable Pediatric Emergency Care Applied Research Network (PECARN) risk category.
Measured: During the index emergency department visit
Modeled Potential Reduction in Head CT Use With a Negative i-STAT TBI Test
The potential incremental reduction in head CT use will be estimated under a strategy in which a negative i-STAT TBI test is used to defer imaging.
Measured: During the index emergency department visit
Diagnostic Performance of Individual GFAP and UCH-L1 Biomarkers
Diagnostic accuracy of GFAP alone and UCH-L1 alone for traumatic findings on head CT. Analyses will also assess the influence of age, mechanism of injury, and time from injury on individual biomarker performance.
Measured: During the index emergency department visit, within 24 hours of injury
Age-Specific Thresholds for a Negative i-STAT TBI Test
Evaluation of whether alternative biomarker thresholds for a negative test within each age group can improve positive predictive value without compromising negative predictive value.
Measured: During the index emergency department visit, within 24 hours of injury
Comparison of Biomarker Measurements Between Tasso+ and Standard Phlebotomy Samples
Biomarker yield, assay validity, quantitative concordance, invalid-result rate, and diagnostic accuracy will be compared between Tasso+ and standard phlebotomy blood samples.
Measured: During the index emergency department visit
Clinical Outcomes Following Pediatric Mild Traumatic Brain Injury
Clinical outcomes will include return emergency department visits, hospital readmission, delayed neurosurgical intervention, repeat or delayed neuroimaging, and functional status.
Measured: Up to 90 days after the index emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Emory University
- Responsible party
- Principal investigator, Andrew Reisner, MD, Children's Healthcare of Atlanta
- Investigators
- Andrew Reisner, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835919
- Sponsor's protocol ID
- STUDY00003099
- Acronym
- KIDS-STAT
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The research team will share deidentified individual participant data underlying the results reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids Injury Detection Study (KIDS-STAT) Using the i-STAT: Point of Care TBI Biomarker Testing
- ClinicalTrials.gov ID
- NCT07835919
- Acronym / sponsor ID
- KIDS-STAT / STUDY00003099
- Keywords
- Biomarkers, Brain imaging, Head CT scan, Pediatric TBI, Diagnostic Accuracy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Collaborators
- Abbott, Emory University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Kids Injury Detection Study using the i-STAT (KIDS-STAT) aims to evaluate whether a rapid blood-based test measuring glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) can accurately identify children with mild traumatic brain injury (mTBI) who do not have acute traumatic findings on head CT. The study will also evaluate test performance across pediatric age groups, assess performance for clinically important TBI and neurosurgically managed lesions, compare biomarker results with PECARN risk categories, and examine whether age, mechanism of injury, and time from injury influence biomarker performance. Clinical outcomes, including return emergency department visits, hospital readmission, delayed neurosurgical intervention, repeat or delayed neuroimaging, and functional status, will also be characterized through 90 days.
The study will enroll children younger than 18 years presenting to the emergency department at Children's Healthcare of Atlanta with suspected non-penetrating mild traumatic brain injury, a Glasgow Coma Scale score of 13-15, and presentation within 24 hours of injury. Participants must have undergone non-contrast head CT as part of their clinical care and have blood collected within 24 hours of injury. Children with penetrating brain injury, presentation outside the 24-hour injury window, or an indeterminate time of injury will not be enrolled.
Participants will undergo a one-time research blood draw during the emergency department visit. Blood will be tested using the i-STAT Alinity TBI system to measure GFAP and UCH-L1, and the biomarker results will be recorded for research analysis. Head CT imaging will be performed as part of standard clinical care, and imaging findings will serve as the reference standard for evaluating biomarker performance. i-STAT results will not be used to guide clinical decision-making or alter patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i-STAT TBI Biomarker Testing | Experimental | Device: i-STAT TBI Cartridge with the i-STAT Alinity SystemParticipants 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. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-STAT TBI Cartridge with the i-STAT Alinity SystemAlso: i-STAT TBI TestA 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. | Device | i-STAT TBI Biomarker Testing |
Primary outcome
Negative Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
Time frame: During the index emergency department visit, within 24 hours of injury
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.
Sensitivity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
Time frame: During the index emergency department visit, within 24 hours of injury
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
11 secondary outcomes
Specificity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
Time frame: 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
Time frame: During the index emergency department visit, within 24 hours of injury
Positive and Negative Likelihood Ratios of the i-STAT Alinity TBI Test
Time frame: 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
Time frame: During the index emergency department visit and through 90 days
Diagnostic Performance of the i-STAT Alinity TBI Test for Neurosurgically Managed Lesions
Time frame: During the index emergency department visit and through 90 days
Association Between i-STAT TBI Test Performance and PECARN Risk Category
Time frame: During the index emergency department visit
Modeled Potential Reduction in Head CT Use With a Negative i-STAT TBI Test
Time frame: During the index emergency department visit
Diagnostic Performance of Individual GFAP and UCH-L1 Biomarkers
Time frame: During the index emergency department visit, within 24 hours of injury
Age-Specific Thresholds for a Negative i-STAT TBI Test
Time frame: During the index emergency department visit, within 24 hours of injury
Comparison of Biomarker Measurements Between Tasso+ and Standard Phlebotomy Samples
Time frame: During the index emergency department visit
Clinical Outcomes Following Pediatric Mild Traumatic Brain Injury
Time frame: Up to 90 days after the index emergency department visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. The research team will share deidentified individual participant data underlying the results reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Reisner, MD principal investigator
Children's Healthcare of Atlanta
Questions about this trial
What is this clinical trial studying?
A study testing i-STAT TBI Cartridge with the i-STAT Alinity System in people with Mild Traumatic Brain Injury and Pediatric Traumatic Brain Injury, run by Children's Healthcare of Atlanta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meena Verma, MD (3102663220, Meena.Verma@choa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT (time frame: During the index emergency department visit, within 24 hours of injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.