Evaluation of Biomarkers of Traumatic Brain Injury (ALERT-TBI)

This study has been completed.
United States Department of Defense
Information provided by (Responsible Party):
Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier:
First received: August 30, 2011
Last updated: September 2, 2015
Last verified: September 2015
The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT scan of the head.

Condition Intervention
Traumatic Brain Injury
Other: Head CT scan and blood draw within 12 hours of injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury

Resource links provided by NLM:

Further study details as provided by Banyan Biomarkers, Inc:

Primary Outcome Measures:
  • Correlation of assay result with absence of acute intracranial lesions [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 2011
Study Start Date: December 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Suspected traumatic brain injury with head CT Other: Head CT scan and blood draw within 12 hours of injury


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects eligible for study participation will be over the age of 18 and present to the health care facility with a head injury at a time such that sample collection can be completed within 12 hours of injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.

Inclusion Criteria:

  • subject is at least 18 years of age at screening
  • suspected traumatically induced head injury as a result of insult to the head from external force
  • GCS 9-15 at time of informed consent
  • workup includes head CT scan as part of clinical emergency care within 3 hours of presenting and within 12 hours of injury
  • blood sample collected within 3 hours of presenting and within 12 hours of injury
  • subject or legal representative is willing to undergo informed consent

Exclusion Criteria:

  • participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study acceptable)
  • time of injury cannot be determined
  • primary diagnosis of ischemic or hemorrhagic stroke
  • venipuncture not feasible
  • a condition precluding entry into the CT scanner
  • subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, and history of neurosurgery, stroke or TIA within the last 30 days
  • administration of blood transfusion after head injury and prior to study blood draw
  • subject is otherwise determined by the Investigator to be unsuitable for participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426919

  Show 24 Study Locations
Sponsors and Collaborators
Banyan Biomarkers, Inc
United States Department of Defense
  More Information

Responsible Party: Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier: NCT01426919     History of Changes
Other Study ID Numbers: ATO-06 
Study First Received: August 30, 2011
Last Updated: September 2, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Hungary: Scientific and Medical Research Council Ethics Committee

Keywords provided by Banyan Biomarkers, Inc:
Traumatic Brain Injury
Head Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2016