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

February 8, 2013 updated by: Banyan Biomarkers, Inc
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of biomarkers to identify patients with TBI from orthopedic controls
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banyan Biomarkers, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATO-04a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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