Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI
Stopped early
Conditions studied: Brain Injuries, Traumatic
In brief
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.
Key facts
- Study ID
- NCT01786447
- Run by
- Banyan Biomarkers, Inc
- People needed
- 111
- Starts
- 2010-04-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2013-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Wayne State University — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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