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Transforming Research And Clinical Knowledge in Geriatric Traumatic Brain Injury (TRACK-GERI)

转变老年创伤性脑损伤的研究和临床知识 (TRACK-GERI)

基本信息

批准号：
10902149
负责人：
Raquel C. Gardner
金额：
$ 12.03万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10902149
关键词：
Accident and Emergency department Address Adult Age Aging Alleles American Anatomy Apolipoprotein E Atrophic Biological Markers Blood Brain Brain Injuries Brain imaging Caring Cause of Death Clinical Clinical Trials Cognitive Cohort Studies Common Data Element Data Dementia Diabetes Mellitus Diagnostic Disabled Persons Elderly Enrollment Enzyme-Linked Immunosorbent Assay Exclusion FDA approved Family Functional disorder Funding Genotype Geriatrics Glial Fibrillary Acidic Protein Gold Guidelines Health Health Status Impaired cognition Incidence Infrastructure Injury Interview Knowledge Measures National Institute of Neurological Disorders and Stroke Natural History Outcome Outcome Assessment Outcome Measure Patients Plasma Polypharmacy Population Prognosis Prognostic Marker Prospective cohort Prospective, cohort study Proxy Public Health Recovery Research Research Design Research Methodology Rest Site Structure TBI Patients Testing Traumatic Brain Injury Variant Vascular Diseases Vulnerable Populations White Matter Disease Withdrawal Work age group biomarker identification blood-based biomarker burden of illness clinical care cohort comorbidity cost demographics design diagnostic biomarker disability effective intervention evidence base evidence based guidelines experience flexibility frailty functional status high risk improved improved outcome injury recovery innovation instrument medical attention mortality multidisciplinary neuropathology novel strategies older patient outcome prediction primary endpoint prognostic prognostic model prognostic tool programs prospective standard measure tool virtual

项目摘要

PROJECT SUMMARY / ABSTRACT Some 2.8 million Americans seek medical attention for traumatic brain injury (TBI) annually, resulting in estimated annual costs of over $75 billion. Older adults have the highest and fastest rising rate of TBI of any other age-group, with 1 in 50 adults age ≥75y seeking medical attention for TBI in 2013. Older adults with TBI experience higher mortality, slower recovery, worse outcomes, and may be at especially high risk for post-TBI dementia. There are few evidence-based guidelines for management, no tools to provide patients and families with reliable estimates of prognosis, and few proven treatments. Progress has been limited by: 1. systematic exclusion of older disabled patients from most prior prospective TBI studies, and 2. lack of age-appropriate TBI research tools. The overall objective is to launch a 2-site prospective geriatric TBI cohort study that will directly address these barriers by applying state-of-the-art geriatric research methods to the field of TBI to improve representation of older patients in TBI research, and to develop a novel approach to measuring age- appropriate TBI predictors, outcomes, blood-based biomarkers, and neuropathology. The approach rests on 2 foundational concepts: 1. Geriatric TBI is different from TBI in younger patients and will require a targeted age- appropriate approach. 2. Baseline health status – including comorbidities/polypharmacy, physical frailty, functional status, and brain structure – is recognized as a key predictor of outcome in the field of geriatrics but is not systematically measured in TBI research. The central hypothesis is that pre-injury health will be extremely heterogeneous in geriatric TBI and will be a key predictor of outcome in this population. An outstanding team of experts in TBI and aging research will achieve these Aims: Aim 1: Assemble a prospective cohort of patients age ≥65y presenting to the Emergency Department ≤72h after TBI who underwent CT. Enroll 270 TBI patient/study-partner dyads and 90 controls; perform baseline assessments and blood draws, and assess longitudinal outcomes at 2wk, 3mo, 6mo (primary endpoint) and 12mo; offer enrollment in a brain donation program. Aim 2: Develop and validate optimized geriatric TBI predictor and outcome assessments: 2a: Systematically measure apolipoprotein E allele and pre-injury comorbidities/polypharmacy, physical frailty, and multi-domain functional status via detailed patient and study partner interviews using validated geriatric instruments and assess association of these predictors with outcome after TBI. 2b: Describe the natural history of geriatric TBI using validated TBI and geriatric outcomes and then use data-driven analytics to identify the most parsimonious set of measures for longitudinal outcome assessment in this population. 2c (exploratory): Measure pre-injury brain structure (atrophy/white matter disease of uninjured brain visualized on baseline CT) and explore association with outcome after TBI. Aim 3: Identify age-appropriate diagnostic and prognostic blood-based biomarkers. This work will directly inform design of large-scale age-appropriate geriatric TBI clinical trials that are urgently needed to improve care and outcomes in this vulnerable population.

项目摘要/摘要