Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1

Phase

N/A

Condition

Memory Loss

Traumatic Brain Injury

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT04602806

W81XWH-18-2-0042

Ages 18-65
All Genders

Study Summary

This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. The study team will enroll a cohort of moderate to severe TBI subjects (N=50), stratified according to VA/DoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling. Subjects will be assessed over 3 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18 - 65y inclusive
History or evidence of TBI, according to DoD-VA criteria
Glasgow Coma Scale (GCS) 3 - 15 after resuscitation in the ED
Head CT with evidence of trauma-related abnormality (except for isolated epiduralhematoma (EDH))
Ability to undergo MRI within 48 hours of injury
Ability to obtain informed consent from participant or Legally AuthorizedRepresentative (LAR) within 6 hours of injury
Fluency in English or Spanish

Exclusion

Exclusion Criteria:

Unstable respiratory or hemodynamic status
Evidence of penetrating brain injury
Isolated EDH as only trauma-related CT abnormality
Systemic traumatic injury that would preclude participation in study, which isexpected to result in long-term disability not related to TBI
Evidence of serious infectious complications (sepsis, bacteremia, multilobarpneumonia)
Acute ischemic heart disease (myocardial infarction or unstable angina)
History of syncope or hypotension
Systolic blood pressure (SBP) < 90 mm Hg, Diastolic blood pressure (DBP)< 40 mm Hgfor longer than 5 minutes
History or evidence of active malignancy
History of pre-existing neurologic disorder, such as dementia, mild cognitiveimpairment, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, priorsevere TBI, or other disorder that may confound interpretation of MRI orneuropsychological results
History of pre-existing disabling mental illness, such as major depression orschizophrenia
History or evidence of chronic heart failure or chronic renal failure
Low likelihood of follow-up (e.g., participant or family indicating low interest,residence in another state or country, unhoused or lack of reliable contacts)
Women who are pregnant or breast-feeding
Prisoners or patients in custody
Patients on psychiatric hold (e.g. 5150, 5250)

Study Design

June 01, 2021

April 09, 2030

Study Description

In 2009, the multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury Consortium was implemented to characterize the clinical, magnetic resonance imaging (MRI), and blood-based biomarker features of TBI to inform design of next-generation precision medicine clinical trials in TBI. Over the past 10+ years, TRACK-TBI has been supported by National Institute of Neurological Disorders and Stroke (NINDS), Department of Defense (DoD), Department of Energy (DoE), the National Football League, and other philanthropic and industry partners. TRACK-TBI has enrolled >3000 control and TBI subjects across the injury spectrum at 18 US Level 1 Trauma Centers. This effort has established the world's largest collection of TBI imaging studies and bio-specimens. The study results are already being adopted into clinical research and bedside practice. The TRACK-TBI Consortium is now primed to deliver on critical military and public health knowledge gaps and needs: objective classification of TBI based on what is termed as "mechanistic" endophenotypes, e.g., diffuse axonal injury (DAI), microvascular injury (MVI), and neuroinflammation. An endophenotype is an internal phenotype discoverable by biochemical, physiological, radiological, pathological, or other techniques, which is intermediate between a complex phenotype and the presumptive genetic or environmental contribution to a disease. Endophenotypes are quantitative, continuous variables, unlike a phenotype which is usually a binary, categorical variable. These mechanistic endophenotypes, defined by imaging and blood-based biomarkers, will direct targeted treatments based on mechanism, providing the tools needed for successful execution of precision medicine clinical trials. To achieve the goal of precision medicine in TBI, it is necessary to identify subgroups of TBI patients that will respond to a targeted therapy. Investigators will assess putative blood-based and neuroimaging biomarkers for DAI, MVI, and neuroinflammation. Fluid biomarkers complement imaging markers and may provide important tools for precision medicine clinical trials. Investigators will collect acute data (early and ultra-early i.e., hours-days following injury), to validate the utility of these biomarkers in defining TBI mechanistic endophenotypes for use in clinical trials.

Specific Aim for TRACK-TBI Precision Medicine Phase 2-Option 1: To validate early and ultra-early blood based and novel imaging biomarkers of DAI, MVI, and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a cohort of moderate-severe subjects.

Connect with a study center

University of California, San Francisco
San Francisco, California 94110
United States
Site Not Available
University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United States
Site Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Site Not Available
University of Utah
Salt Lake City, Utah 84132
United States
Site Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Site Not Available

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