Traumatic Brain Injury Clinical Trials Network

描述（由申请人提供）：这是一份加入多中心临床试验研究网络的提案，重点是创伤性脑损伤。拟议的地点是马里兰大学及其附属医院系统，包括休克创伤中心（STC），这是该州的主要创伤中心，与州EMS直升机和地面运输系统、两家康复医院、Kernan医院和大学专科医院以及社区外展项目关系密切。在上一学年，STC收治了735例创伤性脑损伤患者，其中250例为重度（格拉斯哥昏迷评分[GCS] 3至8），66例为中度损伤（GCS 9至12），147例年龄小于21岁，382例非白人，176例为女性，186例患者出院至系统内两家康复医院之一。所有被提议的研究人员都是马里兰大学医学院的全职教师，神经外科的成员几乎参与了自20世纪80年代中期以来每一个大型的多中心头部损伤研究，包括NIH创伤性昏迷数据库的两个阶段。医学院内还有国家创伤和紧急医疗服务研究中心，其作用是对创伤性损伤进行流行病学研究。如意向书中所述，申请将包括一个概念协议，以在多中心试验中研究治疗。一旦资助期开始，减压开颅术的研究可以在相对较短的时间内开始。虽然这一过程在一些创伤中心进行，但具体的标准尚未确定，短期和长期结果的疗效尚不清楚。虽然这个概念过于简单，但它具有潜在的减轻脑肿胀而没有血肿或挫伤的优势，尽管在损伤过程中的任何特定时间都存在特定的继发性损伤机制或机制。

DESCRIPTION (provided by applicant): This is a proposal to join a multicenter clinical trials research network focused on traumatic brain injury. The proposed site, the University of Maryland and its affiliated hospital system, includes the Shock Trauma Center (STC), the primary trauma center in the State which has close relations with the State EMS helicopter and ground transport systems, two rehabilitation hospitals, Kernan Hospital and the University Specialty Hospital, and community outreach programs. In the last academic year STC admitted 735 patients with traumatic brain injury, 250 were considered severe (Glasgow Coma Score [GCS] 3 to 8), 66 considered moderately injured (GCS 9 to 12), 147 were less than 21 years of age, 382 were other than white, 176 were women, and 186 patients were discharged to one of the two rehabilitation hospitals within the system. All of the proposed investigators are full-time members of the faculty of the University of Maryland School of Medicine, and members of the Department of Neurosurgery have participated in virtually every large multi-centered study of head injury since the mid 1980s, including in both phases of the NIH Traumatic Coma Data Bank. Also within the School of Medicine is the National Study Center for Trauma and Emergency Medical Services whose role is epidemiological study of traumatic injury. As specified in the LOI, the application is to include a concept protocol to study therapy in a multicenter trial. The proposed study of decompression craniotomy could be initiated in a relatively short time once the funding period begins. While this procedure is being done in some trauma centers, specific criteria have not been determined and efficacy with regard to both short and long term outcome is unknown. While the concept is simplistic it has the advantage of potentially mitigating brain swelling without hematoma or contusion, despite the specific mechanism or mechanisms of secondary injury active at any particular time during the course of the injury.