Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma

NCT02541123 | Completed

• 1 other identifier: ATO-12
• Study Type: observational
• Target: 194
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Head Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Cohort A

CT negative for acute intracranial lesion with initial blood draw within 4 hours of head injury

Other: Blood draw

Cohort B

CT negative for acute intracranial lesion with initial blood draw within 4-6 hours of head injury

Other: Blood draw

Cohort C

CT positive for acute intracranial lesion with initial blood draw within 4 hours of head injury

Other: Blood draw

Cohort D

CT positive for acute intracranial lesion with initial blood draw within 4-6 hours of head injury

Other: Blood draw

Cohort E

Uninjured control group

Other: Blood draw

Interventions

Blood draw OTHER

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 A; Cohort B; Cohort C; Cohort D; Cohort E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Banyan Biomarkers, Inc: lead
• United States Department of Defense: collaborator

Study Sites (10)

University of Florida

Gainesville, Florida, 32608, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Klinikum rechts der Isar of the Technical University of Munich

Munich, 81675, Germany

Location

University of Pecs

Pécs, 7632, Hungary

Location

University of Szeged

Szeged, 6725, Hungary

Location

Related 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 Dec 15;37(24):2624-2631. doi: 10.1089/neu.2020.7071. Epub 2020 Sep 14.

  PMID: 32821007 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 4, 2015
• Study Start: January 1, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

US (7); DE (1); HU (2)