Brain Injuries, TraumaticNCT01786460
Brain Injury Biomarkers in the General Population
An observational study of Brain Injuries, Traumatic, run by Banyan Biomarkers, Inc at 5 sites in United States.
Trial summary
The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Blood draw at Days 0, 7, 14, and 21
- How many people
- 800 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2011to Sep 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers who meet eligibility criteria
Who may be able to join
- At least 18 years of age and no more than 80 years of age
- Willing to undergo consent
- PI believes volunteer is appropriate candidate for study
Who cannot join
- Participating in another clinical study that may affect the results of either study
- Non-English speaking
- Venipuncture not feasible
- Blood donation within 1 week of screening
- PI determines volunteer is not medically suitable for study participation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dekalb Medical Center
Decatur, Georgia, 30033
New England Center for Clinical Research
Fall River, Massachusetts, 02720
Shands at University Florida Gainesville
Gainesville, Florida, 32610
Gwinnett Medical Center
Lawrenceville, Georgia, 30045
Office of Nagi S. Ibrahim
Vista, California, 92083
About this study
The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Blood draw at Days 0, 7, 14, and 21
- 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 draw at Days 0, 7, 14, and 21Other
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Not described Receives: Other: Blood draw at Days 0, 7, 14, and 21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the putative biomarkers for TBI markers in general population using an investigational assay
Measured: up to 21 days
Secondary outcomes (1)
Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI
Measured: 0, 14, 7, and 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 800 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
- NCT01786460
- Sponsor's protocol ID
- ATO-05
- Status last verified
- Jan 2017
- First submitted
- 6 Feb 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Injury Biomarkers in the General Population
- ClinicalTrials.gov ID
- NCT01786460
- Acronym / sponsor ID
- ATO-05
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Feb 2013 (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 use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Blood draw at Days 0, 7, 14, and 21 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers who meet eligibility criteria
Key inclusion criteria (3 listed)
- At least 18 years of age and no more than 80 years of age
- Willing to undergo consent
- PI believes volunteer is appropriate candidate for study
Key exclusion criteria (5 listed)
- Participating in another clinical study that may affect the results of either study
- Non-English speaking
- Venipuncture not feasible
- Blood donation within 1 week of screening
- PI determines volunteer is not medically suitable for study participation
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 draw at Days 0, 7, 14, and 21 | Other | Healthy Volunteers |
Primary outcome
Assessment of the putative biomarkers for TBI markers in general population using an investigational assay
Time frame: up to 21 days
1 secondary outcome
Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI
Time frame: 0, 14, 7, and 21 days
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 31 Jan 2017.
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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
5 sites in 1 country: 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 5 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?
The sponsor lists 3 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: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Assessment of the putative biomarkers for TBI markers in general population using an investigational assay (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2017.