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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01786447

Enrollment

111

Registered

2013-02-08

Start date

2010-04-30

Completion date

2011-03-31

Last updated

2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	Time frame
Assessment of biomarkers to identify patients with TBI from orthopedic controls	4 hours

Secondary

Measure	Time frame
Assessment of biomarkers to identify patients with brain lesions on CT scan	4 hours

Other

Measure	Time frame
Assessment of biomarkers to identify patients with acute post-injury alterations in mental status	96 hours
Assessment of biomarkers to identify patients that may have longer-term post-injury neurological deficits using neuropsychological assessments	Day 30

Countries

United States

Outcome results