Brain Injuries, TraumaticNCT01295346
Biomarkers of Mild and Moderate Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by Banyan Biomarkers, Inc at 7 sites in 2 countries.
Trial summary
The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Head CT scan and blood draw
- How many people
- 290 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2011to Mar 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who present to the health care facility with Traumatic Brain Injury (GCS 9-15) within 4 hours of injury.
Who may be able to join
- At least 18 years of age and no more than 80 years of age.
- Closed injury to the head within 4 hours from symptom onset.
- Glasgow Coma Scale (GCS) Score of 9-15.
- Head Computerized Tomography (CT) performed as part of routine care.
- Subject is willing to undergo the Informed Consent process prior to enrollment.
- Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study.
Who cannot join
- Participating in another clinical study that may affect the results of either study.
- Time of injury cannot be determined.
- Head CT not done as part of clinical emergency care.
- Primary diagnosis of ischemic or hemorrhagic infarct.
- Not available for 35 day follow-up visit.
- Venipuncture not feasible.
- Blood donation within 1 week of screening.
- The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Dekalb Medical Center
Decatur, Georgia, 30033
Wayne State University
Detroit, Michigan, 48201
Shands at University Florida Gainesville
Gainesville, Florida, 32610
Gwinnett Medical Center
Lawrenceville, Georgia, 30045
Washington University
St Louis, Missouri, 63110
About this study
The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Head CT scan and blood draw
- 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.
Head CT scan and blood drawOther
| Study group | Role | What they receive |
|---|---|---|
| Traumatic Brain Injury | Patients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury Receives: Other: Head CT scan and blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of putative TBI markers relative to diagnosis
Measured: within 24 hours and at Day 35
Secondary outcomes (1)
Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT)
Measured: within 24 hours and at Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
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 Injuries, TraumaticStudies 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
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banyan Biomarkers, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jackson Streeter, MD, Study chair, Banyan Biomarkers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295346
- Sponsor's protocol ID
- ATO-04b
- Status last verified
- Aug 2017
- First submitted
- 7 Feb 2011
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Welch RD, Ayaz SI, Lewis LM, Unden J, Chen JY, Mika VH, Saville B, Tyndall JA, Nash M, Buki A, Barzo P, Hack D, Tortella FC, Schmid K, Hayes RL, Vossough A, Sweriduk ST, Bazarian JJ. Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B To Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury. J Neurotrauma. 2016 Jan 15;33(2):203-14. doi: 10.1089/neu.2015.4149. Epub 2015 Dec 18.
PubMed 26467555
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Mild and Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01295346
- Acronym / sponsor ID
- ATO-04b
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Feb 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 purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury | – | Other: Head CT scan and blood drawPatients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who present to the health care facility with Traumatic Brain Injury (GCS 9-15) within 4 hours of injury.
Key inclusion criteria (6 listed)
- At least 18 years of age and no more than 80 years of age.
- Closed injury to the head within 4 hours from symptom onset.
- Glasgow Coma Scale (GCS) Score of 9-15.
- Head Computerized Tomography (CT) performed as part of routine care.
- Subject is willing to undergo the Informed Consent process prior to enrollment.
Key exclusion criteria (8 listed)
- Participating in another clinical study that may affect the results of either study.
- Time of injury cannot be determined.
- Head CT not done as part of clinical emergency care.
- Primary diagnosis of ischemic or hemorrhagic infarct.
- Not available for 35 day follow-up visit.
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 | Other | Traumatic Brain Injury |
Primary outcome
Assessment of putative TBI markers relative to diagnosis
Time frame: within 24 hours and at Day 35
1 secondary outcome
Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT)
Time frame: within 24 hours and at Day 35
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 8 Aug 2017.
- Results publication: PubMed 26467555Welch RD, Ayaz SI, Lewis LM, Unden J, Chen JY, Mika VH, Saville B, Tyndall JA, Nash M, Buki A, Barzo P, Hack D, Tortella FC, Schmid K, Hayes RL, Vossough A, Sweriduk ST, Bazarian JJ. Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B To Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury. J Neurotrauma. 2016 Jan 15;33(2):203-14. doi: 10.1089/neu.2015.4149. Epub 2015 Dec 18.
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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.
Jackson Streeter, MD study chair
Banyan Biomarkers
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Banyan Biomarkers, Inc at 7 sites in 2 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, 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?
Assessment of putative TBI markers relative to diagnosis (time frame: within 24 hours and at Day 35). 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 NCT01295346, 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 8 Aug 2017.