Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma (VIGILANT)

December 11, 2020 updated by: Banyan Biomarkers, Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • Klinikum rechts der Isar of the Technical University of Munich
  • Hungary
      • Pecs, Hungary, 7632
        • University of Pecs
      • Szeged, Hungary, 6725
        • University Of Szeged
  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Singer Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 result from the local neuroradiologist and be able to undergo an initial blood draw within 6 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. Subjects enrolled into the control cohort will be recruited from the general population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort A
CT negative for acute intracranial lesion with initial blood draw within 4 hours of head injury
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.
Cohort B
CT negative for acute intracranial lesion with initial blood draw within 4-6 hours of head injury
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.
Cohort C
CT positive for acute intracranial lesion with initial blood draw within 4 hours of head injury
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.
Cohort D
CT positive for acute intracranial lesion with initial blood draw within 4-6 hours of head injury
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.
Cohort E
Uninjured control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in correlation of Banyan UCH-L1/GFAP Detection Assay result with acute intracranial lesions on head CT scan
Time Frame: initial, 4hr, 8hr,12hr,16hr, 20hr, 24hr, Day 7
initial, 4hr, 8hr,12hr,16hr, 20hr, 24hr, Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Banyan Biomarkers, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATO-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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