Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI

Study Overview
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Brief Summary
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The purpose of this study is to determine if specific 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 as well as in orthopedic control subjects.

Conditions
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Brain Injuries, Traumatic

Participation Criteria
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Eligibility Criteria
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Mild/Moderate TBI Group Inclusion Criteria: 18 years or older GCS 9-15 CT scan as part of clinical evaluation experienced some level of altered mental state at time of injury determination of study eligibility within 4 hours of injury Exclusion Criteria: Pregnant females Prisoners Anemia or significant blood loss (hemoglobin < 12 mg/dL and/or hematocrit < 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid) no clear history of trauma as primary event previous history of stroke, or head injury requiring hospitalization dementia or psychotic illness or neurological condition which may affect outcome unable to speak or understand English Orthopedic Control Group Inclusion Criteria: 18 years or older Isolated extracranial orthopedic injury, including fractures Stable vital signs on presentation to ED (pulse < 100bpm and systolic blood pressure > 100 mmHg) Exclusion Criteria: evidence of brain injury, including abnormal neurological examination, alteration in consciousness, memory or mental status, headache, dizziness, or vomiting following injury not enrolled within 4 hours of injury Pregnant females Prisoners Anemia or significant blood loss (hemoglobin < 12 mg/dL and/or hematocrit < 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid) previous history of stroke, or head injury requiring hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traumatic Brain Injury<br>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 | |
| Orthopedic Control<br>Patients who present to the health care facility with isolated extracranial orthopedic injury within 4 hours of injury | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of biomarkers to identify patients with TBI from orthopedic controls |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of biomarkers to identify patients with brain lesions on CT scan |  | 4 hours |