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

Banyan International

Status: Terminated

Conditions: Brain Injuries, Traumatic

Study type: Observational

Funder types: Industry

Identifiers

NCT01786447

ATO-04a

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

111 participants in 2 patient groups

Traumatic Brain Injury

Description:

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

Orthopedic Control

Description:

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