EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY

Traumatic Brain Injury Clinical Trial

— ALERT-TBIx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439736
• Other study ID #: ATO-06x
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: August 7, 2017
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2017
• Source: Banyan Biomarkers, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Blood draw within 12 hours of head injury

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar of the Technical University of Munich	Munich
Germany	Ludwig-Maximilians-University	Munich
United States	University of Virginia	Charlottesville	Virginia
United States	Wayne State University - Detroit Receiving Hospital	Detroit	Michigan
United States	Baylor College of Medicine/Ben Taub General Hospital	Houston	Texas
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Banyan Biomarkers, Inc	U.S. Army Medical Research and Materiel Command

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of assay results with presence of acute intracranial lesions		Day 1