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

Terminated

• Conditions: Brain Injuries, Traumatic

• Registration Number: NCT01786447
• Lead Sponsor: Banyan Biomarkers, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-02
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 111

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of biomarkers to identify patients with TBI from orthopedic controls	4 hours

Secondary Outcome Measures

Name	Time	Method
Assessment of biomarkers to identify patients with brain lesions on CT scan	4 hours

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States