CORE--CLINICAL FACILITY

核心——临床设施

• 批准号: 6445545
• 负责人: Donald W. Marion
• 金额: $ 6.52万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-03-01 至 2002-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6445545
• 关键词: biomedical facility; brain injury; clinical research; critical care; human subject; patient /disease registry; tissue resource /registry

The elucidation of mechanisms of secondary brain injury (the molecular and neurochemical events that occur following impact) which contribute to the morbidity and mortality of victims of severe traumatic brain injury is best accomplished through basic science investigations using animal models of TBI. However, species-specific differences in the type and relative importance of these mechanisms must be considered prior to assuming that mechanisms found to be important in rodents contribute significantly to human secondary injury. Failure to consider and investigate this possible is one likely explanation for the inability of several recent clinical trials to demonstrate efficacy of their study drug after it showed promise in animal studies. The Clinical Core will enable the investigations of the five primary projects to correlate the findings of their basic science investigations in animal models with mechanisms of secondary brain injury in human victims of TBI by: 1. providing appropriately processed and preserved specimens of CSF, dialysate collected during microdialysis of the extracellular space, and brain tissues removed at the time of surgery for evacuation of contusions, 2. assuring high quality, consistent acute care of these patients, 3. providing comprehensive functional and neuropsychological follow-up information about these patients at 3,6 12, and 24 months after injury, and 4. maintaining a detailed clinical database for all of these patients.

通过使用TBI的动物模型进行基础科学研究，最好通过基础科学调查来实现继发性脑损伤机制（在影响后发生的分子和神经化学事件）的机制（发生后发生的分子和神经化学事件）。但是，在假设发现在啮齿动物中很重要的机制对人类的继发性损伤产生显着贡献之前，必须考虑这些机制的类型和相对重要性的物种特异性差异。 未能考虑和研究这一可能是对最近的几项临床试验无法证明其研究药物的功效的一种可能解释，因为它在动物研究中表现出了希望。临床核心将使对动物模型中的基础科学研究的发现与人类受害者的继发性脑损伤的机制相关联，以：1。提供适当处理和保留的CSF标本，透露液在微脑组织中的射精和脑部临时，并保留了适当的疾病和保留的标本，以进行两次渗透的脑组织，并在脑部的脑外部进行了两次审查，并在脑组织外外度进行了审查。这些患者的质量，一致的急性护理，3。提供有关这些患者在3,6 12和受伤后24个月的全面功能和神经心理的随访信息，以及4。为所有这些患者维持详细的临床数据库。