Brain Injuries, TraumaticNCT01786447
Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI
An observational study of Brain Injuries, Traumatic, run by Banyan Biomarkers, Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine if specific 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who present to the health care facility with either Traumatic Brain Injury (GCS 9-15) or isolated extracranial orthopedic injury within 4 hours of injury
Who may be able to join
- 18 years or older
- GCS 9-15
- CT scan as part of clinical evaluation
- experienced some level of altered mental state at time of injury
- determination of study eligibility within 4 hours of injury
- 18 years or older
- Isolated extracranial orthopedic injury, including fractures
- Stable vital signs on presentation to ED (pulse < 100bpm and systolic blood pressure > 100 mmHg)
Who cannot join
- Pregnant females
- Prisoners
- Anemia or significant blood loss (hemoglobin < 12 mg/dL and/or hematocrit < 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
- no clear history of trauma as primary event
- previous history of stroke, or head injury requiring hospitalization
- dementia or psychotic illness or neurological condition which may affect outcome
Show all 14Show fewer
- unable to speak or understand English
- Orthopedic Control Group
- evidence of brain injury, including abnormal neurological examination, alteration in consciousness, memory or mental status, headache, dizziness, or vomiting following injury
- not enrolled within 4 hours of injury
- Pregnant females
- Prisoners
- Anemia or significant blood loss (hemoglobin < 12 mg/dL and/or hematocrit < 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
- previous history of stroke, or head injury requiring hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if specific 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 as well as in orthopedic control subjects.
- Conditions
- Brain Injuries, Traumatic
- 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.
| 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 | |
| Orthopedic Control | Patients who present to the health care facility with isolated extracranial orthopedic injury within 4 hours of injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of biomarkers to identify patients with TBI from orthopedic controls
Measured: 4 hours
Secondary outcomes (1)
Assessment of biomarkers to identify patients with brain lesions on CT scan
Measured: 4 hours
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 startApr 2010
- Primary completionMar 2011
- Study completionMar 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 111 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
- NCT01786447
- Sponsor's protocol ID
- ATO-04a
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI
- ClinicalTrials.gov ID
- NCT01786447
- Acronym / sponsor ID
- ATO-04a
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 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 determine if specific 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 as well as in orthopedic control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Orthopedic Control | – | –Patients who present to the health care facility with isolated extracranial orthopedic injury within 4 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 who present to the health care facility with either Traumatic Brain Injury (GCS 9-15) or isolated extracranial orthopedic injury within 4 hours of injury
Key inclusion criteria (8 listed)
- 18 years or older
- GCS 9-15
- CT scan as part of clinical evaluation
- experienced some level of altered mental state at time of injury
- determination of study eligibility within 4 hours of injury
Key exclusion criteria (14 listed)
- Pregnant females
- Prisoners
- Anemia or significant blood loss (hemoglobin < 12 mg/dL and/or hematocrit < 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
- no clear history of trauma as primary event
- previous history of stroke, or head injury requiring hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of biomarkers to identify patients with TBI from orthopedic controls
Time frame: 4 hours
1 secondary outcome
Assessment of biomarkers to identify patients with brain lesions on CT scan
Time frame: 4 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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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
1 site 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 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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 12 Feb 2013. 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?
The study was stopped early. Results are not available in the source record.
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 biomarkers to identify patients with TBI from orthopedic controls (time frame: 4 hours). 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 12 Feb 2013.