Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma

Traumatic Brain Injury Clinical Trial

— VIGILANT  

Official title:

A Prospective Evaluation of Uch-l1 and Gfap Biomarker Kinetics After Mild Brain Injury Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541123
• Other study ID #: ATO-12
• Status: Completed
• Start date: January 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: December 2020
• Source: Banyan Biomarkers, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured subjects over the age of 18 presenting acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Head Injured Cohorts Inclusion Criteria:

• At least 18 years of age at screening.

• Presented with a suspected traumatically induced head injury, as a result of insult to the head from an external force.

• Workup includes head CT scan, as part of clinical emergency care and CT result (CT-positive or CT-negative for acute intracranial lesions) based on the local neuroradiologist's review is available to study staff.

• CT scan and CT report used to determine eligibility must be available.

• Glasgow Coma Scale score of 13-15 at the time of Informed Consent.

• Weighs at least 110lbs (50kg), has not donated blood within the last 8 weeks, and is not anemic or has any other blood disorder which requires routine transfusions.

• First study blood sample is able to be collected into a cohort that has not been closed to enrollment

• Able to participate for up to 11 days following head injury.

• Subject or legal representative is willing to undergo the Informed Consent process prior to enrollment into this study.

• FOR CT NEGATIVE COHORTS ONLY: Subject must have experienced a Loss of Consciousness (LOC) < 30 minutes, any Alteration of Consciousness (AOC), or any Post-traumatic amnesia (PTA) following the suspected head injury AND be expected to be admitted to the hospital, or remain in hospital for at least 24 hours in order to complete Visit 1 blood draws

Head Injured Cohorts 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

• Neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.

• History of neurosurgery within the last 30 days.

• Administration of blood transfusion after head injury and prior to the study blood draw.

• Female who is pregnant or lactating.

• Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation.

Control Cohort Inclusion Criteria

• At least 18 years of age at screening

• Weighs at least 110lbs (50kg), has not donated blood within the last 8 weeks, and is not anemic or has any other blood disorder which requires routine transfusions.

• Healthy with no chronic or acute medical, neurologic, or psychiatric conditions (to the best of their knowledge).

• Able to participate for up to 5 hours following the first study blood draw.

• Willing to undergo the Informed Consent process prior to enrollment into this study.

• Subject is able to be enrolled into a control cohort that has not yet been closed to enrollment

Control Cohort Exclusion Criteria

• Participating in an interventional, therapeutic clinical study that may affect results of this study (an observational study would be acceptable).

• Subject has sustained any significant bodily injury within the past week.

• 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)).

• Neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.

• Female who is pregnant or lactating

• History of neurosurgery within the last 30 days.

• Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Blood draw
Initial draw followed by additional blood draws every 4 hours thereafter, up to 24 hours from the initial blood draw (not to exceed 7 blood draws). Follow up blood draw at Day 7. Control group only undergoes 2 blood draws 4 hours apart on Day 1.

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar of the Technical University of Munich	Munich
Hungary	University of Pecs	Pecs
Hungary	University of Szeged	Szeged
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Wayne State University	Detroit	Michigan
United States	University of Florida	Gainesville	Florida
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Banyan Biomarkers, Inc	United States Department of Defense

Countries where clinical trial is conducted

United States,  Germany,  Hungary, 

References & Publications (1)

Lewis LM, Papa L, Bazarian JJ, Weber A, Howard R, Welch RD. Biomarkers May Predict Unfavorable Neurological Outcome after Mild Traumatic Brain Injury. J Neurotrauma. 2020 Sep 14. doi: 10.1089/neu.2020.7071. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in correlation of Banyan UCH-L1/GFAP Detection Assay result with acute intracranial lesions on head CT scan		initial, 4hr, 8hr,12hr,16hr, 20hr, 24hr, Day 7