EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY (ALERT-TBIx)

A PROSPECTIVE CLINICAL EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY

The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Blood draw within 12 hours of head injury

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, DE-80336
    • Ludwig-Maximilians-University
  • Munich, Germany, DE-81675
    • Klinikum rechts der Isar of the Technical University of Munich
• United States
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University - Detroit Receiving Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/Ben Taub General Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects eligible for study participation will be over the age of 18 with a standard of care head CT that has been confirmed to be CT-positive for acute intracranial lesions based on the local neuroradiologist's review and can undergo blood draw within 12 hours of head 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.

Description

Inclusion Criteria:

• The Subject is at least 18 years of age at screening.
• The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
• A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
• The subject is CT-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head CT scan.
• The CT scan and CT report used to determine eligibility must be available.
• The blood sample is collected as close to the time of head injury as possible, but no later than 12 hours.
• The Subject or their legal representative is willing to undergo the Informed Consent process prior to enrollment into this study

Exclusion Criteria:

• Participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable).
• Time of injury cannot be determined.
• Primary diagnosis of ischemic or hemorrhagic stroke.
• Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
• The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
• The subject has a history of neurosurgery within the last 30 days.
• Administration of blood transfusion after head injury and prior to the study blood draw.
• The subject is a female who is pregnant or lactating.
• The Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation. If this criterion applies, a reason must be provided

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CT positive for acute intracranial lesion	Other: Blood draw within 12 hours of head injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of assay results with presence of acute intracranial lesions	Day 1

Collaborators and Investigators

• Sponsor: Banyan Biomarkers, Inc
• Collaborators: U.S. Army Medical Research and Development Command

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Head Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: ATO-06x