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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | CT negative for acute intracranial lesion with initial blood draw within 4 hours of head injury |
| |
| Cohort B | CT negative for acute intracranial lesion with initial blood draw within 4-6 hours of head injury |
| |
| Cohort C | CT positive for acute intracranial lesion with initial blood draw within 4 hours of head injury |
| |
| Cohort D | CT positive for acute intracranial lesion with initial blood draw within 4-6 hours of head injury |
| |
| Cohort E | Uninjured control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in correlation of Banyan UCH-L1/GFAP Detection Assay result with acute intracranial lesions on head CT scan | initial, 4hr, 8hr,12hr,16hr, 20hr, 24hr, Day 7 |
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Head Injured Cohorts Inclusion Criteria:
Head Injured Cohorts Exclusion Criteria:
Control Cohort Inclusion Criteria
Control Cohort Exclusion Criteria
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States | ||
| Orlando Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32821007 | Background | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Orlando |
| Florida |
| 32806 |
| United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Allegheny Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Klinikum rechts der Isar of the Technical University of Munich | Munich | 81675 | Germany |
| University of Pecs | Pécs | 7632 | Hungary |
| University of Szeged | Szeged | 6725 | Hungary |
| D020196 |
| Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |