Transforming Research and Clinical Knowledge in Geriatric Traumatic Brain Injury (TRACK-GERI)
NCT ID: NCT07296783
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1500 participants
OBSERVATIONAL
2019-09-02
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TRACK-GERI TBI Patients
TBI patients
No interventions assigned to this group
TRACK-GERI Study Partners of TBI Patients
Study partners of TBI patients
No interventions assigned to this group
TRACK-GERI Controls
Controls
No interventions assigned to this group
TRQACK-GERI Study Partners of Control Patients
Study partners of control patients
No interventions assigned to this group
TRACK-VA TBI Patients
VA TBI patients
No interventions assigned to this group
TRACK-VA Study Partners of TBI Patients
Study partners of VA TBI patients
No interventions assigned to this group
TRACK-VA Controls
VA controls
No interventions assigned to this group
TRACK-VA Study Partners of Control Patients
Study partners of VA control patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Reliable report or physical evidence of head trauma
3. Injury occurred \<72 hours ago (within 14 days of injury for TRACK-VA TBI patients)
4. Acute brain CT for clinical use
5. Fluency in English/Chinese (UCSF only)
6. Ability to obtain informed consent from subject or legally authorized representative
7. Ability to be co-enrolled with a study partner who meets Study Partner enrollment criteria
1. Age 18 years or older
2. Either designated by the patient, presents with patient to the Emergency Department, is listed in the patient's medical chart as an alternate/emergency contact, or is the patient's case manager/social worker, and knows the patient well enough to comment on the patient's health and functional status (e.g. may be family member, friend, caregiver, case manager, etc).
3. Ability to read, write, and speak English/Chinese (UCSF only)
4. Ability to provide informed consent for self
1. Age 65 years or older, no upper age limit
2. Visual acuity/hearing adequate for testing
3. Fluency in English/Chinese (UCSF only)
4. Ability to obtain informed consent from subject or legally authorized representative
5. Ability to be co-enrolled with a study partner who meets study partner enrollment criteria (see control study partner enrollment criteria)
6. For TRACK-VA patients only: Presentation to SFVAMC ED for acute care with planned discharge from ED.
1. Age 18 years or older
2. Designated by the control subject as someone who knows the subject well enough to comment on their health and functional starus (e.g., may be family member, friend, caregiver, case manager, etc.)
3. Ability to read, write and speak English/Chinese (UCSF only)
4. Ability to provide informed consent for self
Exclusion Criteria
2. Prisoners or patients in custody
3. Patients on psychiatric hold (e.g. 5150, 5250)
4. Low likelihood follow-up (participant or family is indicating a low interest, homelessness, out of state/country)
5. Current participation in an interventional trial
6. Penetrating TBI
7. Spinal cord injury with ASIA score of C or worse
8. Acute disabling neurological injury (e.g. acute stroke, cardiac arrest concurrent with head trauma presentation)
1. Pre-existing and major disabling medical, psychiatric, or other neurological disease (e.g. dementia) that interferes with ability to provide evaluation of patient's health and functional status.
2. Prisoners or patients in custody
3. Patients on psychiatric hold (e.g. 5150, 5250)
1. Medically diagnosed with traumatic brain or orthopedic injury in the last year (TRACK-VA Control Subjects are not excluded for orthopedic injuries)
2. Significant polytrauma that would interfere with follow-up and outcome assessment
3. Prisoners or patients in custody
4. Patients on psychiatric hold (e.g. 5150, 5250)
5. Low likelihood follow-up (participant or family is indicating low interest, homelessness, out of state/country)
6. Current participation in an interventional trial
7. Penetrating TBI
8. Spinal cord injury with ASIA score of C or worse
9. Acute disabling neurological injury (e.g. acute stroke, cardiac arrest)
1. Pre-existing and major disabling medical, psychiatric, or other neurological disease (e.g. dementia) that interferes with ability to provide evaluation of control subject's health and functional status.
2. Prisoners or in custody
3. On psychiatric hold (e.g. 5150, 5250)
65 Years
ALL
Yes
Sponsors
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Doris Duke Charitable Foundation
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
National Institute on Aging (NIA)
NIH
United States Department of Defense
FED
US Department of Veterans Affairs
FED
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Geoffrey Manley, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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W81XWH2110469
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TRACK-GERI
Identifier Type: -
Identifier Source: org_study_id