Traumatic Brain InjuryVIGILANTNCT02541123
Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma
An observational study of Traumatic Brain Injury, run by Banyan Biomarkers, Inc at 10 sites in 3 countries.
Trial summary
The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured subjects over the age of 18 presenting acutely with a Glasgow Coma Scale score 13-15 as well… 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
- How many people
- 194 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2016to 28 Feb 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 with a standard of care head CT result from the local neuroradiologist and be able to undergo an initial blood draw within 6 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. Subjects enrolled into the control cohort will be recruited from the general population.
Head Injured Cohorts Inclusion Criteria:
- At least 18 years of age at screening.
- Presented with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
- Workup includes head CT scan, as part of clinical emergency care and CT result (CT-positive or CT-negative for acute intracranial lesions) based on the local neuroradiologist's review is available to study staff.
- CT scan and CT report used to determine eligibility must be available.
- Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
- Weighs at least 110lbs (50kg), has not donated blood within the last 8 weeks, and is not anemic or has any other blood disorder which requires routine transfusions.
- First study blood sample is able to be collected into a cohort that has not been closed to enrollment
- Able to participate for up to 11 days following head injury.
- Subject or legal representative is willing to undergo the Informed Consent process prior to enrollment into this study.
- FOR CT NEGATIVE COHORTS ONLY: Subject must have experienced a Loss of Consciousness (LOC) < 30 minutes, any Alteration of Consciousness (AOC), or any Post-traumatic amnesia (PTA) following the suspected head injury AND be expected to be admitted to the hospital, or remain in hospital for at least 24 hours in order to complete Visit 1 blood draws
Head Injured Cohorts Exclusion Criteria:
- 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
- Neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
- History of neurosurgery within the last 30 days.
- Administration of blood transfusion after head injury and prior to the study blood draw.
- Female who is pregnant or lactating.
- Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation.
Control Cohort Inclusion Criteria
- At least 18 years of age at screening
- Weighs at least 110lbs (50kg), has not donated blood within the last 8 weeks, and is not anemic or has any other blood disorder which requires routine transfusions.
- Healthy with no chronic or acute medical, neurologic, or psychiatric conditions (to the best of their knowledge).
- Able to participate for up to 5 hours following the first study blood draw.
- Willing to undergo the Informed Consent process prior to enrollment into this study.
- Subject is able to be enrolled into a control cohort that has not yet been closed to enrollment
Control Cohort Exclusion Criteria
- Participating in an interventional, therapeutic clinical study that may affect results of this study (an observational study would be acceptable).
- Subject has sustained any significant bodily injury within the past week.
- 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)).
- Neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
- Female who is pregnant or lactating
- History of neurosurgery within the last 30 days.
- Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Wayne State University
Detroit, Michigan, 48201
University of Florida
Gainesville, Florida, 32608
Orlando Regional Medical Center
Orlando, Florida, 32806
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Washington University
St Louis, Missouri, 63110
Germany1 site
Klinikum rechts der Isar of the Technical University of Munich
Munich, 81675
About this study
Official title: A Prospective Evaluation of Uch-l1 and Gfap Biomarker Kinetics After Mild Brain Injury Trauma
The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured subjects over the age of 18 presenting acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control subjects.
- Conditions
- Traumatic Brain Injury
- Being tested
- Blood draw
- 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 drawOther
Initial draw followed by additional blood draws every 4 hours thereafter, up to 24 hours from the initial blood draw (not to exceed 7 blood draws). Follow up blood draw at Day 7. Control group only undergoes 2 blood draws 4 hours apart on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | CT negative for acute intracranial lesion with initial blood draw within 4 hours of head injury Receives: Other: Blood draw | |
| Cohort B | CT negative for acute intracranial lesion with initial blood draw within 4-6 hours of head injury Receives: Other: Blood draw | |
| Cohort C | CT positive for acute intracranial lesion with initial blood draw within 4 hours of head injury Receives: Other: Blood draw | |
| Cohort D | CT positive for acute intracranial lesion with initial blood draw within 4-6 hours of head injury Receives: Other: Blood draw | |
| Cohort E | Uninjured control group Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in correlation of Banyan UCH-L1/GFAP Detection Assay result with acute intracranial lesions on head CT scan
Measured: initial, 4hr, 8hr,12hr,16hr, 20hr, 24hr, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJan 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
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 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
- 194 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
- NCT02541123
- Sponsor's protocol ID
- ATO-12
- Acronym
- VIGILANT
- Status last verified
- Dec 2020
- First submitted
- 31 Aug 2015
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lewis LM, Papa L, Bazarian JJ, Weber A, Howard R, Welch RD. Biomarkers May Predict Unfavorable Neurological Outcome after Mild Traumatic Brain Injury. J Neurotrauma. 2020 Dec 15;37(24):2624-2631. doi: 10.1089/neu.2020.7071. Epub 2020 Sep 14.
PubMed 32821007
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 Evaluation of Uch-l1 and Gfap Biomarker Kinetics After Mild Brain Injury Trauma
- ClinicalTrials.gov ID
- NCT02541123
- Acronym / sponsor ID
- VIGILANT / ATO-12
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Head Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Jan 2016
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 4 Sep 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 the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured subjects over the age of 18 presenting acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Blood drawCT negative for acute intracranial lesion with initial blood draw within 4 hours of head injury |
| Cohort B | – | Other: Blood drawCT negative for acute intracranial lesion with initial blood draw within 4-6 hours of head injury |
| Cohort C | – | Other: Blood drawCT positive for acute intracranial lesion with initial blood draw within 4 hours of head injury |
| Cohort D | – | Other: Blood drawCT positive for acute intracranial lesion with initial blood draw within 4-6 hours of head injury |
| Cohort E | – | Other: Blood drawUninjured control group |
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 result from the local neuroradiologist and be able to undergo an initial blood draw within 6 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. Subjects enrolled into the control cohort will be recruited from the general population.
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 drawInitial draw followed by additional blood draws every 4 hours thereafter, up to 24 hours from the initial blood draw (not to exceed 7 blood draws). Follow up blood draw at Day 7. Control group only undergoes 2 blood draws 4 hours apart on Day 1. | Other | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Change in correlation of Banyan UCH-L1/GFAP Detection Assay result with acute intracranial lesions on head CT scan
Time frame: initial, 4hr, 8hr,12hr,16hr, 20hr, 24hr, Day 7
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 32821007Lewis LM, Papa L, Bazarian JJ, Weber A, Howard R, Welch RD. Biomarkers May Predict Unfavorable Neurological Outcome after Mild Traumatic Brain Injury. J Neurotrauma. 2020 Dec 15;37(24):2624-2631. doi: 10.1089/neu.2020.7071. Epub 2020 Sep 14.
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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.
10 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 10 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?
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 10 sites in United States, Hungary, 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?
Change in correlation of Banyan UCH-L1/GFAP Detection Assay result with acute intracranial lesions on head CT scan (time frame: initial, 4hr, 8hr,12hr,16hr, 20hr, 24hr, Day 7). 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 NCT02541123, 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 16 Dec 2020.