Evaluation of Biomarkers of Traumatic Brain Injury (ALERT-TBI)
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ClinicalTrials.gov Identifier: NCT01426919 |
Recruitment Status :
Completed
First Posted : September 1, 2011
Last Update Posted : December 16, 2020
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Condition or disease | Intervention/treatment |
---|---|
Traumatic Brain Injury | Other: Head CT scan and blood draw within 12 hours of injury |
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 |
Actual Primary Completion Date : | July 2017 |
Actual Study Completion Date : | July 2017 |
Group/Cohort | Intervention/treatment |
---|---|
Suspected traumatic brain injury with head CT |
Other: Head CT scan and blood draw within 12 hours of injury |
- Correlation of assay result with absence of acute intracranial lesions [ Time Frame: Day 1 ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Banyan Biomarkers, Inc |
ClinicalTrials.gov Identifier: | NCT01426919 |
Other Study ID Numbers: |
ATO-06 |
First Posted: | September 1, 2011 Key Record Dates |
Last Update Posted: | December 16, 2020 |
Last Verified: | December 2020 |
Traumatic Brain Injury Head Injury |
Brain Injuries Brain Injuries, Traumatic Wounds and Injuries Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |