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

Brain Injuries, Traumatic Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01786447
• Other study ID #: ATO-04a
• 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

• Brain Injuries
• Brain Injuries, Traumatic

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