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

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ClinicalTrials.gov Identifier: NCT01426919
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Traumatic Brain Injury Other: Head CT scan and blood draw within 12 hours of injury

Study Design

Study Type : Observational
Actual Enrollment : 2011 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury
Study Start Date : December 2012
Primary Completion Date : July 2017
Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Suspected traumatic brain injury with head CT Other: Head CT scan and blood draw within 12 hours of injury

Outcome Measures

Primary Outcome Measures :
  1. Correlation of assay result with absence of acute intracranial lesions [ Time Frame: Day 1 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426919

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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
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

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

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