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

NCT01786447 | Terminated

• 1 other identifier: ATO-04a
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Assessment of biomarkers to identify patients with TBI from orthopedic controls

  4 hours

Secondary Outcomes (1)

• Assessment of biomarkers to identify patients with brain lesions on CT scan

  4 hours

Other Outcomes (2)

• 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

Study Arms (2)

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

Orthopedic Control

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who present to the health care facility with either Traumatic Brain Injury (GCS 9-15) or isolated extracranial orthopedic injury within 4 hours of injury

You may qualify if:

• years or older
• GCS 9-15
• CT scan as part of clinical evaluation
• experienced some level of altered mental state at time of injury
• determination of study eligibility within 4 hours of injury

You may not qualify if:

• Pregnant females
• Prisoners
• 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)
• no clear history of trauma as primary event
• previous history of stroke, or head injury requiring hospitalization
• dementia or psychotic illness or neurological condition which may affect outcome
• unable to speak or understand English
• Orthopedic Control Group
• years or older
• Isolated extracranial orthopedic injury, including fractures
• Stable vital signs on presentation to ED (pulse \< 100bpm and systolic blood pressure \> 100 mmHg)
• evidence of brain injury, including abnormal neurological examination, alteration in consciousness, memory or mental status, headache, dizziness, or vomiting following injury
• not enrolled within 4 hours of injury
• Pregnant females
• Prisoners

Sponsors & Collaborators

• Banyan Biomarkers, Inc: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jackson Streeter, MD

  Banyan Biomarkers

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: April 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

US (1)