Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:2/1/2017
Start Date:January 2016
Contact:Steve Richieri
Email:srichieri@banyanbio.com
Phone:760-710-0453

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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.


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
We found this trial at
8
sites
Pittsburgh, Pennsylvania 15212
Principal Investigator: Charles Feronti, DO
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Dedrick Jordan, MD PhD
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Robert Welch, MD
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Joseph Tyndall, MD MPH
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1414 Kuhl Avenue
Orlando, Florida 32806
Principal Investigator: Linda Papa, MD
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Orlando, FL
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: David Okonkwo, MD PhD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Principal Investigator: Lawrence Lewis, MD
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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22 Ismaninger Straße
Munich, 81675
Principal Investigator: Peter Biberthaler, MD
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Munich,
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