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The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumatic Brain Injury | Patients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head CT scan and blood draw | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of putative TBI markers relative to diagnosis | within 24 hours and at Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT) | within 24 hours and at Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pituitary status and determination of the presence of autoantibodies | Day 35 |
Inclusion Criteria:
Exclusion Criteria:
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Subjects who present to the health care facility with Traumatic Brain Injury (GCS 9-15) within 4 hours of injury.
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| Name | Affiliation | Role |
|---|---|---|
| Jackson Streeter, MD | Banyan Biomarkers | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands at University Florida Gainesville | Gainesville | Florida | 32610 | United States | ||
| Dekalb Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26467555 | Result | Welch RD, Ayaz SI, Lewis LM, Unden J, Chen JY, Mika VH, Saville B, Tyndall JA, Nash M, Buki A, Barzo P, Hack D, Tortella FC, Schmid K, Hayes RL, Vossough A, Sweriduk ST, Bazarian JJ. Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B To Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury. J Neurotrauma. 2016 Jan 15;33(2):203-14. doi: 10.1089/neu.2015.4149. Epub 2015 Dec 18. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| 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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Whole blood, serum, plasma
| Decatur |
| Georgia |
| 30033 |
| United States |
| Gwinnett Medical Center | Lawrenceville | Georgia | 30045 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Pecs | Pécs | Hungary |
| University of Szeged | Szeged | Hungary |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |