NCT07296783Enrolling By Invitation不适用
Transforming Research and Clinical Knowledge in Geriatric Traumatic Brain Injury (TRACK-GERI)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Functional Outcome at 6 Months Post-Injury as Assessed by the Glasgow Outcome Scale-Extended (GOSE)
研究概览
简要总结
The purpose of this study is to improve the diagnosis and prediction of recovery after traumatic brain injury (TBI) in adults age 65 years and older. The study will follow older adults who present to the emergency department after TBI, as well as matched control participants, and will measure clinical features, brain imaging, and blood-based biomarkers over 12 months to understand how recovery changes over time. Researchers will examine how pre-injury health, brain structure, and biological markers are related to disability and cognitive outcomes after TBI. Information from this study will be used to develop age-appropriate tools to better diagnose TBI and estimate long-term outcomes in older adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years and older, no upper age limit
- •Reliable report or physical evidence of head trauma
- •Injury occurred <72 hours ago (within 14 days of injury for TRACK-VA TBI patients)
- •Acute brain CT for clinical use
- •Fluency in English/Chinese (UCSF only)
- •Ability to obtain informed consent from subject or legally authorized representative
- •Ability to be co-enrolled with a study partner who meets Study Partner enrollment criteria
排除标准
- •Significant polytrauma that would interfere with follow-up and outcome assessment
- •Prisoners or patients in custody
- •Patients on psychiatric hold (e.g. 5150, 5250)
- •Low likelihood follow-up (participant or family is indicating a low interest, homelessness, out of state/country)
- •Current participation in an interventional trial
- •Penetrating TBI
- •Spinal cord injury with ASIA score of C or worse
- •Acute disabling neurological injury (e.g. acute stroke, cardiac arrest concurrent with head trauma presentation)
- •TRACK-GERI/VA STUDY PARTNERS OF TBI PATIENTS INCLUSION/EXCLUSION CRITERIA
- •Inclusion Criteria:
- •Age 18 years or older
- •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).
- •Ability to read, write, and speak English/Chinese (UCSF only)
- •Ability to provide informed consent for self
- •Exclusion Criteria:
- •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.
- •Prisoners or patients in custody
- •Patients on psychiatric hold (e.g. 5150, 5250)
- •TRACK-GERI/VA CONTROL SUBJECT INCLUSION/EXCLUSION CRITERIA
- •Inclusion Criteria:
- •Age 65 years or older, no upper age limit
- •Visual acuity/hearing adequate for testing
- •Fluency in English/Chinese (UCSF only)
- •Ability to obtain informed consent from subject or legally authorized representative
- •Ability to be co-enrolled with a study partner who meets study partner enrollment criteria (see control study partner enrollment criteria)
- •For TRACK-VA patients only: Presentation to SFVAMC ED for acute care with planned discharge from ED.
- •Exclusion Criteria:
- •Medically diagnosed with traumatic brain or orthopedic injury in the last year (TRACK-VA Control Subjects are not excluded for orthopedic injuries)
- •Significant polytrauma that would interfere with follow-up and outcome assessment
- •Prisoners or patients in custody
- •Patients on psychiatric hold (e.g. 5150, 5250)
- •Low likelihood follow-up (participant or family is indicating low interest, homelessness, out of state/country)
- •Current participation in an interventional trial
- •Penetrating TBI
- •Spinal cord injury with ASIA score of C or worse
- •Acute disabling neurological injury (e.g. acute stroke, cardiac arrest)
- •TRACK-GERI/VA STUDY PARTNERS OF CONTROL SUBJECTS INCLUSION/EXCLUSION CRITERIA
- •Inclusion Criteria:
- •Age 18 years or older
- •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.)
- •Ability to read, write and speak English/Chinese (UCSF only)
- •Ability to provide informed consent for self
- •Exclusion Criteria:
- •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.
- •Prisoners or in custody
- •On psychiatric hold (e.g. 5150, 5250)
结局指标
主要结局
Functional Outcome at 6 Months Post-Injury as Assessed by the Glasgow Outcome Scale-Extended (GOSE)
时间窗: 6 months post-injury
Functional outcome after traumatic brain injury will be measured using the Glasgow Outcome Scale-Extended (GOSE). The score ranges from 1-8, with higher scores indicating better recovery. The primary outcome is GOSE assessed at 6 months post-injury.
次要结局
未报告次要终点
研究者
研究点 (3)
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