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

This study has been completed.
Sponsor:
Collaborator:
United States DoD MRMC
Information provided by (Responsible Party):
Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier:
NCT01426919
First received: August 30, 2011
Last updated: June 2, 2014
Last verified: June 2014

August 30, 2011
June 2, 2014
December 2012
March 2014   (final data collection date for primary outcome measure)
Correlation of assay result with absence of acute intracranial lesions [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01426919 on ClinicalTrials.gov Archive Site
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Evaluation of Biomarkers of Traumatic Brain Injury
A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Traumatic Brain Injury
Other: Head CT scan and blood draw within 12 hours of injury
Suspected traumatic brain injury with head CT
Intervention: Other: Head CT scan and blood draw within 12 hours of injury
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2011
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Hungary
 
NCT01426919
ATO-06
No
Banyan Biomarkers, Inc
Banyan Biomarkers, Inc
United States DoD MRMC
Not Provided
Banyan Biomarkers, Inc
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP