Traumatic Brain InjuryALERT-TBINCT01426919
Evaluation of Biomarkers of Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Banyan Biomarkers, Inc at 24 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT… 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?
- Head CT scan and blood draw within 12 hours of injury
- How many people
- 2,011 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Dec 2012to Jul 2017
- 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: Subjects eligible for study participation will be over the age of 18 and present to the health care facility with a head injury at a time such that sample collection can be completed within 12 hours of injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.
Who may be able to join
- subject is at least 18 years of age at screening
- suspected traumatically induced head injury as a result of insult to the head from external force
- GCS 9-15 at time of informed consent
- workup includes head CT scan as part of clinical emergency care within 3 hours of presenting and within 12 hours of injury
- blood sample collected within 3 hours of presenting and within 12 hours of injury
- subject or legal representative is willing to undergo informed consent
Who cannot join
- participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study acceptable)
- time of injury cannot be determined
- primary diagnosis of ischemic or hemorrhagic stroke
- venipuncture not feasible
- a condition precluding entry into the CT scanner
- subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, and history of neurosurgery, stroke or TIA within the last 30 days
- administration of blood transfusion after head injury and prior to study blood draw
- subject is otherwise determined by the Investigator to be unsuitable for participation
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States17 sites
University Medical Center Brackenridge
Austin, Texas, 78701
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908
Carilion New River Valley
Christiansburg, Virginia, 24073
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, 48201
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, 48235
University of Florida
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06102
Baylor College of Medicine/Ben Taub General Hospital
Houston, Texas, 77030
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14642
University of California San Diego
San Diego, California, 92103
University of Washington
Seattle, Washington, 98104
Washington University
St Louis, Missouri, 63110
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Germany5 sites
Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200
Charité Universitätsmedizin Berlin - Campus Virchow Klinikum
Berlin, D-13353
University of Heidelberg
Heidelberg, DE-69120
Ludwig-Maximilians-University
Munich, DE-80336
Klinikum rechts der Isar of the Technical University of Munich
Munich, DE-81675
Hungary2 sites
University of Pecs
Pécs, 7623
University of Szeged, Albert Szent Gyorgi Medical Center
Szeged, 6725
About this study
Official title: A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury
The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT scan of the head.
- Conditions
- Traumatic Brain Injury
- Being tested
- Head CT scan and blood draw within 12 hours of injury
- Keywords
- Traumatic Brain Injury, Head Injury
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head CT scan and blood draw within 12 hours of injuryOther
| Study group | Role | What they receive |
|---|---|---|
| Suspected traumatic brain injury with head CT | Not described Receives: Other: Head CT scan and blood draw within 12 hours of injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of assay result with absence of acute intracranial lesions
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startDec 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 2,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banyan Biomarkers, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426919
- Sponsor's protocol ID
- ATO-06
- Acronym
- ALERT-TBI
- Status last verified
- Dec 2020
- First submitted
- 30 Aug 2011
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ward MD, Weber A, Merrill VD, Welch RD, Bazarian JJ, Christenson RH. Predictive Performance of Traumatic Brain Injury Biomarkers in High-Risk Elderly Patients. J Appl Lab Med. 2020 Jan 1;5(1):91-100. doi: 10.1093/jalm.2019.031393.
PubMed 32445344Bazarian 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 30054151Bazarian JJ, Welch RD, Caudle K, Jeffrey CA, Chen JY, Chandran R, McCaw T, Datwyler SA, Zhang H, McQuiston B. Accuracy of a rapid glial fibrillary acidic protein/ubiquitin carboxyl-terminal hydrolase L1 test for the prediction of intracranial injuries on head computed tomography after mild traumatic brain injury. Acad Emerg Med. 2021 Nov;28(11):1308-1317. doi: 10.1111/acem.14366. Epub 2021 Sep 7.
PubMed 34358399
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01426919
- Acronym / sponsor ID
- ALERT-TBI / ATO-06
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Head Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,011 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Dec 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Sep 2011 (estimated)
- 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 primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT scan of the head.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected traumatic brain injury with head CT | – | Other: Head CT scan and blood draw within 12 hours of injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects eligible for study participation will be over the age of 18 and present to the health care facility with a head injury at a time such that sample collection can be completed within 12 hours of injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.
Key inclusion criteria (6 listed)
- subject is at least 18 years of age at screening
- suspected traumatically induced head injury as a result of insult to the head from external force
- GCS 9-15 at time of informed consent
- workup includes head CT scan as part of clinical emergency care within 3 hours of presenting and within 12 hours of injury
- blood sample collected within 3 hours of presenting and within 12 hours of injury
Key exclusion criteria (8 listed)
- participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study acceptable)
- time of injury cannot be determined
- primary diagnosis of ischemic or hemorrhagic stroke
- venipuncture not feasible
- a condition precluding entry into the CT scanner
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 |
|---|---|---|
| Head CT scan and blood draw within 12 hours of injury | Other | Suspected traumatic brain injury with head CT |
Primary outcome
Correlation of assay result with absence of acute intracranial lesions
Time frame: Day 1
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 16 Dec 2020.
- Background: PubMed 32445344Ward MD, Weber A, Merrill VD, Welch RD, Bazarian JJ, Christenson RH. Predictive Performance of Traumatic Brain Injury Biomarkers in High-Risk Elderly Patients. J Appl Lab Med. 2020 Jan 1;5(1):91-100. doi: 10.1093/jalm.2019.031393.
- Results publication: 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.
- Derived from this study: PubMed 34358399Bazarian JJ, Welch RD, Caudle K, Jeffrey CA, Chen JY, Chandran R, McCaw T, Datwyler SA, Zhang H, McQuiston B. Accuracy of a rapid glial fibrillary acidic protein/ubiquitin carboxyl-terminal hydrolase L1 test for the prediction of intracranial injuries on head computed tomography after mild traumatic brain injury. Acad Emerg Med. 2021 Nov;28(11):1308-1317. doi: 10.1111/acem.14366. Epub 2021 Sep 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 3 countries: 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 Banyan Biomarkers, Inc at 24 sites in 3 countries.
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 6 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: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Germany, Hungary. 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?
Correlation of assay result with absence of acute intracranial lesions (time frame: Day 1). 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 NCT01426919, which also lists 3 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 16 Dec 2020.