Clinical trial NCT01295346: Biomarkers of Mild and Moderate Traumatic Brain Injury
Official title: Biomarkers of Mild and Moderate Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Lead sponsor: Banyan Biomarkers, Inc
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who present to the health care facility with Traumatic Brain Injury (GCS 9-15) within 4 hours of injury.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Assessment of putative TBI markers relative to diagnosis
timeFrame: within 24 hours and at Day 35
Secondary outcomes:
measure: Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT)
timeFrame: within 24 hours and at Day 35
Other outcomes:
measure: Assessment of pituitary status and determination of the presence of autoantibodies
timeFrame: Day 35
Locations:
city: Gainesville
country: United States
facility: Shands at University Florida Gainesville
state: Florida
city: Decatur
country: United States
facility: Dekalb Medical Center
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Pecs
country: Hungary
facility: University of Pecs
city: Szeged
country: Hungary
facility: University of Szeged
Study officials:
affiliation: Banyan Biomarkers
name: Jackson Streeter, MD
role: STUDY_CHAIR
References:
citation: Welch RD, Ayaz SI, Lewis LM, Unden J, Chen JY, Mika VH, Saville B, Tyndall JA, Nash M, Buki A, Barzo P, Hack D, Tortella FC, Schmid K, Hayes RL, Vossough A, Sweriduk ST, Bazarian JJ. Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B To Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury. J Neurotrauma. 2016 Jan 15;33(2):203-14. doi: 10.1089/neu.2015.4149. Epub 2015 Dec 18.