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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 : December 16, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Banyan Biomarkers, Inc

Tracking Information
First Submitted Date August 30, 2011
First Posted Date September 1, 2011
Last Update Posted Date December 16, 2020
Study Start Date December 2012
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2012)
Correlation of assay result with absence of acute intracranial lesions [ Time Frame: Day 1 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Biomarkers of Traumatic Brain Injury
Official Title A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Traumatic Brain Injury
Intervention Other: Head CT scan and blood draw within 12 hours of injury
Study Groups/Cohorts Suspected traumatic brain injury with head CT
Intervention: Other: Head CT scan and blood draw within 12 hours of injury
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2014)
2011
Original Estimated Enrollment
 (submitted: August 31, 2011)
1650
Actual Study Completion Date July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Hungary,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01426919
Other Study ID Numbers ATO-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Banyan Biomarkers, Inc
Original Responsible Party Same as current
Current Study Sponsor Banyan Biomarkers, Inc
Original Study Sponsor Same as current
Collaborators United States Department of Defense
Investigators Not Provided
PRS Account Banyan Biomarkers, Inc
Verification Date December 2020