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

NCT ID: NCT01786447

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Traumatic Brain Injury

Patients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury

No interventions assigned to this group

Orthopedic Control

Patients who present to the health care facility with isolated extracranial orthopedic injury within 4 hours of injury

No interventions assigned to this group

Eligibility Criteria

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

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. 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Banyan Biomarkers, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jackson Streeter, MD

Role: STUDY_CHAIR

Banyan Biomarkers

Locations

Wayne State University

Detroit, Michigan, United States

Countries

United States

Other Identifiers

ATO-04a

Identifier Type: -

Identifier Source: org_study_id