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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01426919
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
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.
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


  Hide Study Locations
Locations
United States, California
University of California San Diego
San Diego, California, United States, 92103
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, United States, 48235
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University Medical Center Brackenridge
Austin, Texas, United States, 78701
Baylor College of Medicine/Ben Taub General Hospital
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Carilion New River Valley
Christiansburg, Virginia, United States, 24073
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Germany
Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, D-12200
Charité Universitätsmedizin Berlin - Campus Virchow Klinikum
Berlin, Germany, D-13353
University of Heidelberg
Heidelberg, Germany, DE-69120
Ludwig-Maximilians-University
Munich, Germany, DE-80336
Klinikum rechts der Isar of the Technical University of Munich
Munich, Germany, DE-81675
Hungary
University of Pecs
Pecs, Hungary, 7623
University of Szeged, Albert Szent Gyorgi Medical Center
Szeged, Hungary, 6725
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