Brain InjuriesBRAIN-CTNCT06932588
Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
A study testing Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT in people with Brain Injuries and Head Injury, run by Emory University at 1 site in United States.
Trial summary
This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Head Injury
- What is being tested?
- Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2025to Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Mild TBI, defined as Glasgow Coma Scale (GCS) score 13-15, presenting within 24 hours of injury
- No prior head imaging for the same incident
- Presenting within 24 hours of onset of injury
Who cannot join
- Patients with penetrating head injury
- History of known brain abnormality including tumor, cerebrovascular malformation, recent brain surgery (within 6 months), prior head injury (within 6 months)
- Need for emergent surgical intervention for brain or alternate body organ injury
- Need for emergent bedside procedures for hemodynamic or orthopedic stabilization
- Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging.
In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).
Read the detailed description
The Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma (BRAIN-CT) study aims to determine whether immediate access to blood biomarker data can help doctors decide when a CT scan is necessary for patients with mild traumatic brain injury (mTBI). The study will also explore how biomarker data influences clinical outcomes, such as hospital stay duration, costs, and recovery. Additionally, it will identify specific patient groups where biomarker results may alter imaging decisions, assess the ability of biomarkers to predict worsening symptoms and develop predictive models to improve the accuracy of these tests compared to CT scans.
The study will enroll adults presenting with suspected mild traumatic brain injury (mTBI) in the emergency department at Grady Memorial Hospital. Minors, pregnant individuals, wards of the state, prisoners, and those with cognitive impairments will not be enrolled.
Participants will undergo blood-based biomarker testing upon ED presentation. Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.
- Conditions
- Brain Injuries, Head Injury
- Being tested
- Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT
- Keywords
- Biomarkers, Brain imaging, Brain trauma, Head CT scan, Mild traumatic brain injury (mTBI)
- Medical subject headings
- Brain Injuries, Craniocerebral Trauma, Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STATDiagnostic test
Also called i-STAT TBI
The i-STAT TBI cartridge is a point-of-care, whole-blood, biomarker-based assay that measures the level of biomarkers associated with brain injury in the bloodstream 24 hours after injury. Blood samples (5-10cc of whole blood) will be collected upon admission during a routine blood drawing in the ED. These samples will be tested using the iSTAT system for mild TBI biomarkers.
In a subset of admitted patients, serial blood draws and iSTAT testing will be performed at 4, 8, 16, and 24 hours, depending on the patient's length of stay.
| Study group | Role | What they receive |
|---|---|---|
| Published Biomarker Group | Experimental | Biomarker results are provided to the ED provider immediately and before the decision to order a head CT is made. A print-out of the results will be handed to the provider or uploaded to the epic platform. Receives: Diagnostic Test: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT |
| Blinded Biomarker Group | Active comparator | Biomarker results are not disclosed during the decision-making process for cranial imaging. Receives: Diagnostic Test: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants having a CT head scan from biomarker positive
The impact of biomarker results will be measured by the decision to obtain CT head imaging for patients presenting with mild TBI.
Measured: During hospital admission (average 15 days).
Secondary outcomes (4)
Length of hospital stay
Length of hospital stay until discharge
Measured: Hospital admission (average 15) days.
Number of participants with intracranial findings predicted by biomarker findings
In participants undergoing CT head imaging, the proportion of participants with intracranial findings between biomarker-positive and biomarker-negative groups will be compared.
Measured: Hospital admission (average 15) days.
Number of readmissions for TBI-related symptoms
Data will be taken from electronic medical records (EMR) and participant's interviews.
Measured: up to 6 months after hospital discharge
Glasgow Outcome Scale-Extended (GOS-E)
Functional outcome measured by the GOS-E. The Glasgow Outcome Scale-Extended (GOS-E) is one of the most widely used outcome instruments to assess global disability and recovery after traumatic brain injury. The patient's overall rating is based on the lowest outcome category indicated on the scale. The overall rating is the lowest outcome category indicated by the person's answers (after discounting limitations or problems before injury). Deaths are taken from records, and on the GOS-E rating schema, a vegetative state (VS) or a score of 2 is the lowest category, and Upper Good Recovery (Upper GR) or a score of 8 is the highest. If the person has no limitations or impaired symptoms, their GOS-E rating is Upper GR (8).
Measured: 6 and 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start31 May 2025
- Primary completion9 Jul 2026
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Jonathan A. Grossberg, Emory University
- Investigators
- Jonathan Grossberg, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932588
- Sponsor's protocol ID
- STUDY00008711
- Other IDs
- 2025P010295
- Acronym
- BRAIN-CT
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Publications
Tfaily A, Chacon A, Ma T, Ratcliff J, Smith R, Saad H, Reisner A, Gimbel D, Wang K, Kobeissy F, Grossberg JA, Alawieh AM. Biomarker role in assessing imaging needs for mild cranial trauma (BRAIN-CT): study protocol for a single-center, randomized controlled trial. Front Neurol. 2026 Jan 9;16:1692163. doi: 10.3389/fneur.2025.1692163. eCollection 2025.
PubMed 41586091
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
- ClinicalTrials.gov ID
- NCT06932588
- Acronym / sponsor ID
- BRAIN-CT / STUDY00008711
- Conditions
- Brain Injuries, Head Injury
- Keywords
- Biomarkers, Brain imaging, Brain trauma, Head CT scan, Mild traumatic brain injury (mTBI)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 31 May 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Apr 2025 (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.
This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging.
In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).
Detailed description
The Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma (BRAIN-CT) study aims to determine whether immediate access to blood biomarker data can help doctors decide when a CT scan is necessary for patients with mild traumatic brain injury (mTBI). The study will also explore how biomarker data influences clinical outcomes, such as hospital stay duration, costs, and recovery. Additionally, it will identify specific patient groups where biomarker results may alter imaging decisions, assess the ability of biomarkers to predict worsening symptoms and develop predictive models to improve the accuracy of these tests compared to CT scans.
The study will enroll adults presenting with suspected mild traumatic brain injury (mTBI) in the emergency department at Grady Memorial Hospital. Minors, pregnant individuals, wards of the state, prisoners, and those with cognitive impairments will not be enrolled.
Participants will undergo blood-based biomarker testing upon ED presentation. Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Published Biomarker Group | Experimental | Diagnostic Test: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STATBiomarker results are provided to the ED provider immediately and before the decision to order a head CT is made. A print-out of the results will be handed to the provider or uploaded to the epic platform. |
| Blinded Biomarker Group | Active comparator | Diagnostic Test: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STATBiomarker results are not disclosed during the decision-making process for cranial imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Mild TBI, defined as Glasgow Coma Scale (GCS) score 13-15, presenting within 24 hours of injury
- No prior head imaging for the same incident
- Presenting within 24 hours of onset of injury
Key exclusion criteria (5 listed)
- Patients with penetrating head injury
- History of known brain abnormality including tumor, cerebrovascular malformation, recent brain surgery (within 6 months), prior head injury (within 6 months)
- Need for emergent surgical intervention for brain or alternate body organ injury
- Need for emergent bedside procedures for hemodynamic or orthopedic stabilization
- Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing.
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 |
|---|---|---|
| Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STATAlso: i-STAT TBIThe i-STAT TBI cartridge is a point-of-care, whole-blood, biomarker-based assay that measures the level of biomarkers associated with brain injury in the bloodstream 24 hours after injury. Blood samples (5-10cc of whole blood) will be collected upon admission during a routine blood drawing in the ED. These samples will be tested using the iSTAT system for mild TBI biomarkers. In a subset of admitted patients, serial blood draws and iSTAT testing will be performed at 4, 8, 16, and 24 hours, depending on the patient's length of stay. | Diagnostic test | Blinded Biomarker Group, Published Biomarker Group |
Primary outcome
Proportion of participants having a CT head scan from biomarker positive
Time frame: During hospital admission (average 15 days).
The impact of biomarker results will be measured by the decision to obtain CT head imaging for patients presenting with mild TBI.
4 secondary outcomes
Length of hospital stay
Time frame: Hospital admission (average 15) days.
Number of participants with intracranial findings predicted by biomarker findings
Time frame: Hospital admission (average 15) days.
Number of readmissions for TBI-related symptoms
Time frame: up to 6 months after hospital discharge
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: 6 and 12 months after hospital discharge
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 7 Aug 2026.
- Derived from this study: PubMed 41586091Tfaily A, Chacon A, Ma T, Ratcliff J, Smith R, Saad H, Reisner A, Gimbel D, Wang K, Kobeissy F, Grossberg JA, Alawieh AM. Biomarker role in assessing imaging needs for mild cranial trauma (BRAIN-CT): study protocol for a single-center, randomized controlled trial. Front Neurol. 2026 Jan 9;16:1692163. doi: 10.3389/fneur.2025.1692163. eCollection 2025.
- 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. This study is not recruiting at the moment.
Jonathan Grossberg, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT in people with Brain Injuries and Head Injury, run by Emory University at 1 site in United States.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants having a CT head scan from biomarker positive (time frame: During hospital admission (average 15 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932588, which also lists 1 linked publication.
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 7 Aug 2026.