NCT01786447TerminatedNot Applicable
Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Banyan Biomarkers, Inc
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Assessment of biomarkers to identify patients with TBI from orthopedic controls
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •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
- •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
- •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
Outcomes
Primary Outcomes
Assessment of biomarkers to identify patients with TBI from orthopedic controls
Time Frame: 4 hours
Secondary Outcomes
- Assessment of biomarkers to identify patients with brain lesions on CT scan(4 hours)
Investigators
Study Sites (1)
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