Evaluation of Biomarkers of Traumatic Brain Injury (ALERT-TBI)
This study is currently recruiting participants.
Verified April 2013 by Banyan Biomarkers, Inc
Sponsor:
Banyan Biomarkers, Inc
Collaborator:
United States DoD MRMC
Information provided by (Responsible Party):
Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier:
NCT01426919
First received: August 30, 2011
Last updated: April 18, 2013
Last verified: April 2013
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Purpose
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 | Intervention |
|---|---|
|
Traumatic Brain Injury |
Other: Head CT scan and blood draw within 12 hours of injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury |
Resource links provided by NLM:
Further study details as provided by Banyan Biomarkers, Inc:
Primary Outcome Measures:
- Correlation of assay result with absence of acute intracranial lesions [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Suspected traumatic brain injury with head CT | Other: Head CT scan and blood draw within 12 hours of injury |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426919
Contacts
| Contact: Steve Richieri | 760.710.0453 | srichieri@banyanbio.com |
Locations
| United States, Connecticut | |
| Hartford Hospital | Recruiting |
| Hartford, Connecticut, United States, 06102 | |
| Principal Investigator: Sandeep Johar, DO | |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Principal Investigator: Latha G Stead, MD | |
| Tallahassee Neurological Clinic | Recruiting |
| Tallahassee, Florida, United States, 32308 | |
| Principal Investigator: Christopher Rumana, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Principal Investigator: Robert Welch, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: Lawrence M Lewis, MD | |
| United States, New York | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: Jeffrey J Bazarian, MD MPH | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: Dedrick Jordan, MD PhD | |
| Hungary | |
| University of Pecs | Recruiting |
| Pecs, Hungary, 7623 | |
| Principal Investigator: Andras Buki, MD Dsc | |
Sponsors and Collaborators
Banyan Biomarkers, Inc
United States DoD MRMC
More Information
No publications provided
| Responsible Party: | Banyan Biomarkers, Inc |
| ClinicalTrials.gov Identifier: | NCT01426919 History of Changes |
| Other Study ID Numbers: | ATO-06 |
| Study First Received: | August 30, 2011 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Banyan Biomarkers, Inc:
|
Traumatic Brain Injury Head Injury |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013