Traumatic Brain InjuryALERT-TBIxNCT02439736
EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY
An observational study of Traumatic Brain Injury, run by Banyan Biomarkers, Inc at 7 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma… 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 within 12 hours of head injury
- How many people
- 119 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2015to Nov 2016
- 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 with a standard of care head CT that has been confirmed to be CT-positive for acute intracranial lesions based on the local neuroradiologist's review and can undergo blood draw within 12 hours of head 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
- The Subject is at least 18 years of age at screening.
- The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
- A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
- The subject is CT-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head CT scan.
- The CT scan and CT report used to determine eligibility must be available.
- The blood sample is collected as close to the time of head injury as possible, but no later than 12 hours.
- The Subject or their legal representative is willing to undergo the Informed Consent process prior to enrollment into this study
Who cannot join
- Participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable).
- Time of injury cannot be determined.
- Primary diagnosis of ischemic or hemorrhagic stroke.
- Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
- The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
- The subject has a history of neurosurgery within the last 30 days.
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- Administration of blood transfusion after head injury and prior to the study blood draw.
- The subject is a female who is pregnant or lactating.
- The Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation. If this criterion applies, a reason must be provided
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
University of Virginia
Charlottesville, Virginia, 22908
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, 48201
Baylor College of Medicine/Ben Taub General Hospital
Houston, Texas, 77030
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California San Diego
San Diego, California, 92103
Germany2 sites
Ludwig-Maximilians-University
Munich, DE-80336
Klinikum rechts der Isar of the Technical University of Munich
Munich, DE-81675
About this study
Official title: A PROSPECTIVE CLINICAL EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY
The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).
- Conditions
- Traumatic Brain Injury
- Being tested
- Blood draw within 12 hours of head 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.
Blood draw within 12 hours of head injuryOther
| Study group | Role | What they receive |
|---|---|---|
| CT positive for acute intracranial lesion | Not described Receives: Other: Blood draw within 12 hours of head injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of assay results with presence 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 posted12 May 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banyan Biomarkers, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439736
- Sponsor's protocol ID
- ATO-06x
- Acronym
- ALERT-TBIx
- Status last verified
- Aug 2017
- First submitted
- 7 May 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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
- A PROSPECTIVE CLINICAL EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY
- ClinicalTrials.gov ID
- NCT02439736
- Acronym / sponsor ID
- ALERT-TBIx / ATO-06x
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Head Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jun 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 May 2015 (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 Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT positive for acute intracranial lesion | – | Other: Blood draw within 12 hours of head 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 with a standard of care head CT that has been confirmed to be CT-positive for acute intracranial lesions based on the local neuroradiologist's review and can undergo blood draw within 12 hours of head 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 (7 listed)
- The Subject is at least 18 years of age at screening.
- The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
- A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
- The subject is CT-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head CT scan.
- The CT scan and CT report used to determine eligibility must be available.
Key exclusion criteria (9 listed)
- Participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable).
- Time of injury cannot be determined.
- Primary diagnosis of ischemic or hemorrhagic stroke.
- Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
- The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
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 within 12 hours of head injury | Other | CT positive for acute intracranial lesion |
Primary outcome
Correlation of assay results with presence 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 8 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Traumatic Brain Injury, 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 7 inclusion and 9 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, Germany. 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 results with presence 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?
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.