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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01786447
Other study ID # ATO-04a
Secondary ID
Status Terminated
Phase N/A
First received February 6, 2013
Last updated February 8, 2013
Start date April 2010
Est. completion date March 2011

Study information

Verified date February 2013
Source Banyan Biomarkers, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 111
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wayne State University Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Banyan Biomarkers, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of biomarkers to identify patients with acute post-injury alterations in mental status 96 hours No
Other Assessment of biomarkers to identify patients that may have longer-term post-injury neurological deficits using neuropsychological assessments Day 30 No
Primary Assessment of biomarkers to identify patients with TBI from orthopedic controls 4 hours No
Secondary Assessment of biomarkers to identify patients with brain lesions on CT scan 4 hours No
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