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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/摘要每年约有280万美国人因创伤性脑损伤(TBI)寻求医疗护理，导致估计每年的成本超过750亿美元。老年人的脑损伤上升速度最快、最快。其他年龄段，≥75岁的成年人中每50人中就有1人在2013年因脑外伤寻求医疗救治。老年脑外伤患者经历更高的死亡率，更慢的恢复，更差的结果，并可能处于特别高的脑外伤后风险痴呆症。几乎没有循证的管理指南，没有工具为患者和家属提供对预后有可靠的估计，几乎没有经过验证的治疗方法。进展受到以下因素的限制：1.系统性将老年残疾患者排除在大多数先前的前瞻性脑损伤研究之外，以及2.缺乏与年龄相适应的脑损伤研究工具。总体目标是启动一项两个地点的前瞻性老年脑损伤队列研究，将直接通过将最先进的老年学研究方法应用于脑外伤领域来解决这些障碍，以改善老年患者在脑损伤研究中的代表性，并开发一种新的方法来测量年龄- 合适的脑损伤预测因素、结果、基于血液的生物标记物和神经病理学。该方法依赖于2 基本概念：1.老年性脑外伤不同于年轻患者的脑外伤，需要有针对性的年龄-- 适当的方法。2.基线健康状况--包括合并症/多药、身体虚弱、功能状态和大脑结构-在老年病学领域被认为是预后的关键预测因素，但在TBI研究中没有系统地测量。核心假设是受伤前的健康状况将是老年性脑外伤的异质性很强，这将是这一人群预后的关键预测因素。一个 TBI和老龄化研究领域的优秀专家团队将实现这些目标：目标1：集合未来的年龄为≥65岁的患者在颅脑损伤后72小时到急诊科≤接受CT检查。报名 270名脑损伤患者/研究伙伴二人组和90名对照；执行基线评估和抽血，以及评估2周、3个月、6个月(主要终点)和12个月的纵向结果；提供大脑注册捐赠计划。目标2：开发和验证优化的老年脑损伤预测指标和结果评估：系统地检测载脂蛋白E等位基因和损伤前的合并症/多药、身体虚弱、通过使用经过验证的老年患者和研究伙伴的详细访谈，了解多领域的功能状态评估这些预测因素与脑外伤后预后的关系。2B：描述自然历史使用有效的TBI和老年结果来评估老年脑损伤，然后使用数据驱动的分析来确定在这一人群中进行纵向结果评估的最简明的一套措施。2C(探索性)：测量损伤前的脑结构(在基线CT上显示未损伤的脑萎缩/白质疾病) 并探讨其与颅脑损伤后预后的关系。目标3：确定适合年龄的诊断和预后基于血液的生物标记物。这项工作将直接为大规模适龄老年脑外伤的设计提供参考迫切需要进行临床试验，以改善这一弱势群体的护理和结果。