Traumatic Brain InjuryNCT04171960
Clinical Evaluation of the i-STAT TBI Test
An observational study of Traumatic Brain Injury, run by Abbott Point of Care at 21 sites in United States.
Trial summary
The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI). Patients will be asked to provide a blood sample. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Blood draw and Outcome assessments
- How many people
- 1,106 participants
- Where
- 21 sitesUnited States
- Study dates
- 31 Jul 2020to 29 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Study population consisted of patients who are 18 years of age or older presenting to the Healthcare Facility with suspected mild TBI*, a GCS score of 13-15 and within 24 hours of head injury. *TBI includes the head being struck or striking an object, or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head.
Acute Blood Biomarker Branch Subject Inclusion Criteria:
- 18 years of age or older.
- Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
- Subject presented to a health care facility or emergency department with a suspected TBI resulting from an insult to the head by an external force within 12 hours of the injury.
- Subject has a CT scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility or are transferred to the enrolling facility with a head CT scan sent from the originating facility.
- As a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following.
- Any period of loss of consciousness
- Any loss of memory for events immediately before or after the injury
- Any alteration of mental state at the time of the injury
- Focal neurological deficits that may or may not be transient
Acute Blood Biomarker Branch Subject Exclusion Criteria.
- Previous enrollment in this study
- Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
- Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
- Time of injury is unknown and cannot be estimated
- Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association [ASIA] score of C or worse) at the enrolling facility
- Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge
- Prisoners or patients in custody
- Patients on psychiatric hold
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Texas, Austin
Austin, Texas, 78701
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rehabilitation Hospital of Indiana
Carmel, Indiana, 46032
University of Cincinnati
Cincinnati, Ohio, 45219
University of Texas, South Western
Dallas, Texas, 75390
Denver Health and Hospital Authority
Denver, Colorado, 80204
Craig Hospital
Englewood, Colorado, 80113
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Health Sciences Center of Houston
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Kentucky
Lexington, Kentucky, 40536
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwauke, Wisconsin, 53226
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98104
About this study
The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).
Patients will be asked to provide a blood sample.
Read the detailed description
The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a computed tomography (CT) scan in patients presenting with suspected mild traumatic brain injury (TBI) who are 18 years of age or older.
The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.
- Conditions
- Traumatic Brain Injury
- Being tested
- Blood draw, Outcome assessments
- Keywords
- i-STAT, Traumatic Brain Injury, Biomarkers
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Venous whole blood collection within 12 hours and 12-24 hours following injury.
Outcome assessmentsOther
Administered at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Acute Blood Biomarker Branch | Blood drawn within 12 hours or 12-24 hours following injury for i-STAT TBI Testing and in-person baseline outcome assessments. Receives: Diagnostic Test: Blood draw; Other: Outcome assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings.
Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings (+/-) for intra-cranial lesions for each subject.
Measured: Within 24 Hours of Traumatic Brain Injury (TBI)
Clinical performance measurement of the i-STAT TBI Test.
Clinical performance metrics included, clinical sensitivity, clinical specificity, negative predictive value (NPV), positive predictive value (PPV), adjusted negative predictive value (adj. NPV) calculated to a 6% CT positive prevalence rate, negative likelihood ratio (neg. LR) and positive likelihood ratio (pos. LR).
Measured: Within 24 hours of Traumatic Brain Injury (TBI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start31 Jul 2020
- Primary completion26 Jun 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Point of Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Manish Gupta, MS, MBA, Study director, Abbott Point of Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171960
- Sponsor's protocol ID
- CS-2018-0009
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2019
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Plan is currently undecided.
Publications
Papa L, Brophy GM, Welch RD, Lewis LM, Braga CF, Tan CN, Ameli NJ, Lopez MA, Haeussler CA, Mendez Giordano DI, Silvestri S, Giordano P, Weber KD, Hill-Pryor C, Hack DC. Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury. JAMA Neurol. 2016 May 1;73(5):551-60. doi: 10.1001/jamaneurol.2016.0039.
PubMed 27018834Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Buki A, Chen JY, Christenson RH, Hack D, Huff JS, Johar S, Jordan JD, Leidel BA, Lindner T, Ludington E, Okonkwo DO, Ornato J, Peacock WF, Schmidt K, Tyndall JA, Vossough A, Jagoda AS. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018 Sep;17(9):782-789. doi: 10.1016/S1474-4422(18)30231-X. Epub 2018 Jul 24.
PubMed 30054151
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the i-STAT TBI Test
- ClinicalTrials.gov ID
- NCT04171960
- Acronym / sponsor ID
- CS-2018-0009
- Conditions
- Traumatic Brain Injury
- Keywords
- i-STAT, Traumatic Brain Injury, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,106 participants (actual)
- Lead sponsor
- Abbott Point of CareIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, University of California, San Francisco
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 21 Nov 2019 (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.
The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).
Patients will be asked to provide a blood sample.
Detailed description
The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a computed tomography (CT) scan in patients presenting with suspected mild traumatic brain injury (TBI) who are 18 years of age or older.
The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Blood Biomarker Branch | – | Diagnostic Test: Blood draw, Other: Outcome assessmentsBlood drawn within 12 hours or 12-24 hours following injury for i-STAT TBI Testing and in-person baseline outcome assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consisted of patients who are 18 years of age or older presenting to the Healthcare Facility with suspected mild TBI*, a GCS score of 13-15 and within 24 hours of head injury. *TBI includes the head being struck or striking an object, or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head.
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 |
|---|---|---|
| Blood drawVenous whole blood collection within 12 hours and 12-24 hours following injury. | Diagnostic test | Acute Blood Biomarker Branch |
| Outcome assessmentsAdministered at baseline. | Other | Acute Blood Biomarker Branch |
Primary outcome
i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings.
Time frame: Within 24 Hours of Traumatic Brain Injury (TBI)
Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings (+/-) for intra-cranial lesions for each subject.
Clinical performance measurement of the i-STAT TBI Test.
Time frame: Within 24 hours of Traumatic Brain Injury (TBI)
Clinical performance metrics included, clinical sensitivity, clinical specificity, negative predictive value (NPV), positive predictive value (PPV), adjusted negative predictive value (adj. NPV) calculated to a 6% CT positive prevalence rate, negative likelihood ratio (neg. LR) and positive likelihood ratio (pos. LR).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 27018834Papa L, Brophy GM, Welch RD, Lewis LM, Braga CF, Tan CN, Ameli NJ, Lopez MA, Haeussler CA, Mendez Giordano DI, Silvestri S, Giordano P, Weber KD, Hill-Pryor C, Hack DC. Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury. JAMA Neurol. 2016 May 1;73(5):551-60. doi: 10.1001/jamaneurol.2016.0039.
- Background: PubMed 30054151Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Buki A, Chen JY, Christenson RH, Hack D, Huff JS, Johar S, Jordan JD, Leidel BA, Lindner T, Ludington E, Okonkwo DO, Ornato J, Peacock WF, Schmidt K, Tyndall JA, Vossough A, Jagoda AS. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018 Sep;17(9):782-789. doi: 10.1016/S1474-4422(18)30231-X. Epub 2018 Jul 24.
- Individual participant dataSharing planned: Undecided. Plan is currently undecided.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Manish Gupta, MS, MBA study director
Abbott Point of Care
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Abbott Point of Care at 21 sites 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?
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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings. (time frame: Within 24 Hours of Traumatic Brain Injury (TBI)). 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?
On the ClinicalTrials.gov record for NCT04171960, which also lists 2 linked publications.
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 29 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.