Transforming Research and Clinical Knowledge in Traumatic Brain Injury

改变创伤性脑损伤的研究和临床知识

• 批准号: 8644167
• 负责人: Ramon Diaz-Arrastia
• 金额: $ 373.59万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8644167
• 关键词: Achievement; Age; Anatomy; Antiplatelet Drugs; Beds; Biological Markers; Blood; Brain Concussion; Candidate Disease Gene; Caring; Categories; Classification; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Design; Cognition; Cognitive; Collaborations; Coma; Common Data Element; Craniotomy; Data; Data Set; Databases; Development; Diagnosis; Diagnostic; Diffusion Magnetic Resonance Imaging; Direct Costs; Economic Burden; Enrollment; Facilities and Administrative Costs; Floor; Functional Magnetic Resonance Imaging; Future; Future Generations; Genetic Markers; Genetic Polymorphism; Genomics; Glasgow Outcome Scale; Goals; Gold; Home environment; Image; Industry; Industry Collaborators; Informatics; Injury; International; Intervention; Intracranial Hemorrhages; Knowledge; Lead; Life; Magnetic Resonance Imaging; Mental Health; Methods; Mission; Molecular; Neurocognitive; Neuropsychological Tests; Outcome; Outcome Assessment; Outpatients; Patients; Phase; Phenotype; Pilot Projects; Proteomics; Public Health; Quality of life; Recovery; Research; Research Infrastructure; Research Personnel; Resources; Rest; Sample Size; Services; Severities; Site; Stratification; System; Taxonomy; Testing; Time; Traumatic Brain Injury; Treatment outcome; Validation; base; clinical practice; comparative effectiveness; compare effectiveness; cost; disability; economic impact; effective therapy; effectiveness research; experience; flexibility; follow-up; forging; functional status; health economics; improved; indexing; next generation; novel strategies; outcome forecast; prognostic; public health relevance; public-private partnership; repaired; repository; response to injury; social; tool

DESCRIPTION (provided by applicant): Effective treatment of traumatic brain injury (TBI) remains one of the greatest unmet needs in public health. Each year in the US, at least 1.7 million people suffer TBI; an estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and psychological health disabilities of TBI, with annual direct and indirect costs estimated at over $60 billion. The unique public-private partnership of investigators, philanthropy, and industry leaders brought together in the multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) proposal share a mission to accelerate clinical research in TBI. The goal is to create a large, high quality TBI database that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers, and provides analytic tools and resources to establish more precise methods for TBI diagnosis and prognosis, improve outcome assessment, and compare the effectiveness and costs of tests, treatments, and services. The investigators hypothesize that this approach will deliver better characterization and stratification of patients, allowing meaningful comparisons of treatments and outcomes and thereby improving the next generation of clinical trials. Specific Aim 1. To create a widely accessible, comprehensive TBI Information Commons that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers from subjects across the age and injury spectra, and provides analytic tools and resources to support TBI research. Specific Aim 2. To validate imaging, proteomic, and genetic biomarkers that will improve classification of TBI, permit appropriate selection and stratification of patients for clinical trils, and contribute to the development of a new taxonomy for TBI. Specific Aim 3. To evaluate a flexible outcome assessment battery comprised of a broad range of TBI common data elements that enables assessment of multiple outcome domains across all phases of recovery and at all levels of TBI severity. Specific Aim 4. To determine which tests, treatments, and services are effective and appropriate for which TBI patients, and use this evidence to recommend practices that offer the best value. The project will directly impact public health by creating an open-access Information Commons populated with robust Common Data Elements that will make international research collaboration a reality. Detailed clinical data on 3,000 subjects (11 sites) across the injury spectrum, along with CT/MRI imaging, blood biospecimens, and detailed outcomes, will be collected and analyzed, permitting the identification/validation of biomarkers, and identification of structural abnormalities that may be predictive of outcomes, making strides toward a new taxonomy for TBI. The infrastructure of integrated databases and imaging and biosample repositories will create a high quality, legacy database for current and future generations of international researchers.

描述（由申请人提供）：有效治疗创伤性脑损伤（TBI）仍然是公共卫生中最大的未满足需求之一。每年在美国，至少有170万人遭受TBI；估计有3.2至530万人生活在长期的身体上 TBI的认知和心理健康障碍，年度直接和间接成本估计超过600亿美元。研究人员，慈善事业和行业领导者的独特公私伙伴关系汇集了创伤性脑损伤的多中心转变研究和临床知识（TRACK-TBI）提案，分享了在TBI中加速临床研究的使命。目的是创建一个大型，高质量的TBI数据库，该数据库整合临床，成像，蛋白质组学，基因组和结果生物标志物，并提供分析工具和资源，以建立更精确的TBI诊断和预后，改善结果评估，并比较测试，治疗和服务的有效性和成本。研究人员假设这种方法将对患者进行更好的表征和分层，从而可以进行有意义的治疗和结果比较，从而改善下一代临床试验。 特定目标1。创建一个广泛访问的全面的TBI信息共享，以整合来自整个年龄和伤害谱系受试者的临床，成像，蛋白质组学，基因组和结果生物标志物，并提供分析工具和资源来支持TBI研究。 具体目的2。验证将改善TBI分类的成像，蛋白质组学和遗传生物标志物，允许对患者进行适当的选择和分层进行临床三LIL，并为TBI的新分类法开发出来。 具体目标3。评估由TBI广泛的共同数据元素组成的灵活结果评估电池，该电池能够评估恢复的所有阶段和所有TBI严重程度的各个阶段的多个结果域。 特定目标4。确定哪些测试，治疗和服务是有效且适合TBI患者的，并使用此证据推荐提供最佳价值的实践。该项目将通过创建一个带有强大的通用数据元素的开放访问信息共识来直接影响公共卫生，这将使国际研究合作成为现实。将收集和分析有关3,000名受试者的3,000名受试者（11个地点）的详细临床数据，以及CT/MRI成像，血液生物测量和详细结果，并允许生物标志物的识别/验证，并识别可能对抗量的结构异常的识别，可以预测到越来越多的成果，使其对新的分类构成新的分类。集成数据库和成像和生物样品存储库的基础架构将为当代和后代的国际研究人员创建高质量的旧数据库。