Biomarkers of Mild and Moderate Traumatic Brain Injury

Completed

Conditions studied: Brain Injuries, Traumatic

In brief

The purpose of this study is to assess if putative 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. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.

Key facts

Study ID

NCT01295346

Run by

Banyan Biomarkers, Inc

People needed

290

Starts

2011-01-01

Expected to finish

2012-03-01

Last updated by the study team

2017-08-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age and no more than 80 years of age.
• Closed injury to the head within 4 hours from symptom onset.
• Glasgow Coma Scale (GCS) Score of 9-15.
• Head Computerized Tomography (CT) performed as part of routine care.
• Subject is willing to undergo the Informed Consent process prior to enrollment.
• Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study.

You may not qualify if…

• Participating in another clinical study that may affect the results of either study.
• Time of injury cannot be determined.
• Head CT not done as part of clinical emergency care.
• Primary diagnosis of ischemic or hemorrhagic infarct.
• Not available for 35 day follow-up visit.
• Venipuncture not feasible.
• Blood donation within 1 week of screening.
• The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Where it is running

• Shands at University Florida Gainesville — Gainesville, Florida, United States
• Dekalb Medical Center — Decatur, Georgia, United States
• Gwinnett Medical Center — Lawrenceville, Georgia, United States
• Wayne State University — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• University of Pecs — Pécs, Hungary
• University of Szeged — Szeged, Hungary

Full record on ClinicalTrials.gov

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