Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma
NCT ID: NCT02541123
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
194 participants
OBSERVATIONAL
2016-01-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
CT negative for acute intracranial lesion with initial blood draw within 4 hours of head injury
Blood draw
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.
Cohort B
CT negative for acute intracranial lesion with initial blood draw within 4-6 hours of head injury
Blood draw
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.
Cohort C
CT positive for acute intracranial lesion with initial blood draw within 4 hours of head injury
Blood draw
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.
Cohort D
CT positive for acute intracranial lesion with initial blood draw within 4-6 hours of head injury
Blood draw
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.
Cohort E
Uninjured control group
Blood draw
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.
Interventions
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Blood draw
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Banyan Biomarkers, Inc
INDUSTRY
Responsible Party
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Locations
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University of Florida
Gainesville, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Wayne State University
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Klinikum rechts der Isar of the Technical University of Munich
Munich, , Germany
University of Pecs
Pécs, , Hungary
University of Szeged
Szeged, , Hungary
Countries
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References
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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.
Other Identifiers
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ATO-12
Identifier Type: -
Identifier Source: org_study_id