Clinical trial NCT01786447: Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Injuries, Traumatic
Lead sponsor: Banyan Biomarkers, Inc
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who present to the health care facility with either Traumatic Brain Injury (GCS 9-15) or isolated extracranial orthopedic injury within 4 hours of injury

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.


Eligibility criteria: Mild/Moderate TBI Group

Inclusion Criteria:

1. 18 years or older
2. GCS 9-15
3. CT scan as part of clinical evaluation
4. experienced some level of altered mental state at time of injury
5. determination of study eligibility within 4 hours of injury

Exclusion Criteria:

1. Pregnant females
2. Prisoners
3. 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)
4. no clear history of trauma as primary event
5. previous history of stroke, or head injury requiring hospitalization
6. dementia or psychotic illness or neurological condition which may affect outcome
7. unable to speak or understand English

Orthopedic Control Group

Inclusion Criteria:

1. 18 years or older
2. Isolated extracranial orthopedic injury, including fractures
3. Stable vital signs on presentation to ED (pulse \< 100bpm and systolic blood pressure \> 100 mmHg)

Exclusion Criteria:

1. evidence of brain injury, including abnormal neurological examination, alteration in consciousness, memory or mental status, headache, dizziness, or vomiting following injury
2. not enrolled within 4 hours of injury
3. Pregnant females
4. Prisoners
5. 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)
6. previous history of stroke, or head injury requiring hospitalization

Primary outcomes:
measure: Assessment of biomarkers to identify patients with TBI from orthopedic controls
timeFrame: 4 hours
Secondary outcomes:
measure: Assessment of biomarkers to identify patients with brain lesions on CT scan
timeFrame: 4 hours
Other outcomes:
measure: Assessment of biomarkers to identify patients with acute post-injury alterations in mental status
timeFrame: 96 hours
measure: Assessment of biomarkers to identify patients that may have longer-term post-injury neurological deficits using neuropsychological assessments
timeFrame: Day 30
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Banyan Biomarkers
name: Jackson Streeter, MD
role: STUDY_CHAIR
References: