Core B: Human Subjects Core: Multiple Organ Failure Database And Tissue Bank

核心 B：人类受试者 核心：多器官衰竭数据库和组织库

• 批准号: 8382286
• 负责人: ERNEST EUGENE MOORE
• 金额: $ 23.42万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8382286
• 关键词: Area; Basic Science; Caring; Cells; Cessation of life; Clinical; Clinical Data; Clinical Sciences; Collaborations; Collection; Consent; Critical Care; Critical Illness; Data; Data Analyses; Databases; Development; Disease; Ensure; Grant; Human; Liquid substance; Monitor; Multiple Organ Failure; Outcome; Pathogenesis; Patients; Population; Protocols documentation; Registries; Research Personnel; Resuscitation; Risk; Risk Factors; Sampling; Standardization; System; Tissue Banking; Tissue Banks; Tissues; Translational Research; Trauma; United States; Update; blood product; human subject; human subject protection; improved; injured; insight; patient oriented research; years of life lost

Trauma remains the leading cause of years of life lost in the United States and multiple organ failure (MOF) is the primary cause of late postinjury death. The Human Subjects Core (HSC) will coordinate the patient-oriented research of the "Trauma Primes Cells" RCTBPI Grant. Given that a large portion of this proposal focuses on the study of injured and/or critically ill patients, the HSC is recommended as an effective manner to coordinate the development and implementation of standard protocols, recruitment and consent of subjects, as well as collection and appropriate storage/distribution of samples and clinical data. This proposal for the HSC has four major functions: 1) to continue to maximize two-way translational research from basic to clinical science and vice-versa within the Center as well as through collaborations with other investigators; 2) to conduct timely studies to investigate significant clinical questions regarding resuscitation protocols and management of postinjury critical care patients; 3) to refine, improve and update scoring systems for monitoring critical care patients, most especially the Denver MOF score, and 4) to conduct hypotheses generating studies to stimulate new sets of questions at the basic and clinical science level. To support these functions, two strategies are proposed: 1) MOF database: this detailed clinical registry of over 2000 critically injured patients at risk for MOF, initiated over a decade ago, and to our knowledge, the largest, sustained clinical database of its kind; and 2) Tissue Databank: initiated 5 years ago during our last cycle, this consists of discarded tissue and fluid samples of patients included in the MOF database (therefore with complete clinical and laboratorial data) appropriately stored and available for translational research. Analysis of these data provides pivotal insights on risk factors, outcome and possible mechanisms for the pathogenesis of postinjury MOF as well as landmark findings with direct implications to resuscitation protocols, especially in the area of blood products use, and management of critical care patients. It is important to emphasize that trauma patients provide a particularly appealing subpopulation, mostly young and free of comorbid disease, minimizing confounding and facilitating the interpretation of the results. Findings in this population often have implications for the management of other critical care populations, amplifying the scope and impact of our findings. In addition, we are improving standardization of care, while ensuring protection of human subjects, and maximizing translational science.

创伤仍然是美国丧生多年的主要原因，而多器官衰竭（MOF）是后期后期死亡的主要原因。人类受试者核心（HSC）将协调“创伤素细胞” RCTBPI赠款的面向患者的研究。鉴于该提案的很大一部分侧重于对受伤和/或重症患者的研究，因此建议将HSC作为协调标准方案的开发和实施，招聘的有效方式 和受试者的同意，以及样本和临床数据的收集和适当的存储/分布。 HSC的这一建议具有四个主要功能：1）继续通过与其他研究人员的合作来最大化从基础科学到临床科学到临床科学，反之亦然的双向转化研究； 2）进行及时的研究，以调查有关复苏方案的重大临床问题和对后重症监护后患者的管理； 3）用于改进，改进和更新用于监测重症监护患者的评分系统，尤其是丹佛MOF得分，4） 进行假设生成研究，以刺激基本和临床科学层面的新问题集。为了支持这些功能，提出了两种策略：1）MOF数据库：该详细的临床注册表有2000多名严重受伤的MOF风险患者，十年前启动了，据我们所知，这是此类持续的最大，持续的临床数据库；和2）组织数据库：5年前在我们的最后一个周期中启动，由MOF数据库中包含的患者的丢弃的组织和流体样本组成（因此具有完整的临床和实验室数据），适当地存储了并用于转化研究。对这些数据的分析提供了有关危险因素，结果和可能的机制的关键见解，以及对复苏方案的直接影响，尤其是在血液产品使用领域以及对重症监护患者的管理方面，具有直接影响。重要的是要强调，创伤患者提供了一个特别有吸引力的亚群，主要是年轻且没有合并症，从而最大程度地减少了混杂并促进结果的解释。该人群中的发现通常对管理其他重症监护群体的管理有影响，从而扩大了我们发现的范围和影响。此外，我们正在改善护理的标准化，同时确保保护人类受试者并最大化转化科学。