An interventional study of i-STAT TBI Cartridge with the i-STAT Alinity System in Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury and Head Trauma, sponsored by Children's Healthcare of Atlanta. Not yet recruiting. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Children's Healthcare of Atlanta · Not applicable, Interventional, and Diagnostic
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.
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 700 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →Children's Healthcare of Atlanta is the lead sponsor of 97 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: 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
Time frame: During the index emergency department visit, within 24 hours of injury
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).
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
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).
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
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).
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
Diagnostic performance of the i-STAT Alinity TBI whole-blood test for identifying clinically important traumatic brain injury (ciTBI).
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
Diagnostic performance of the i-STAT Alinity TBI whole-blood test for identifying traumatic intracranial lesions requiring neurosurgical management.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 days after the index emergency department visit
No study locations are listed for this record.
Plan to share: Yes — 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2031, 60 months later.
Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 60 months is above that.
Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Healthcare of Atlanta