Traumatic Brain Injury Clinical Trials Network

描述(由申请人提供)：这是一项加入多中心临床试验研究网络的建议，重点是创伤性脑损伤。拟建地点马里兰大学及其附属医院系统包括休克创伤中心(STC)，这是该州与州立EMS直升机和地面运输系统关系密切的主要创伤中心，两家康复医院，科南医院和大学专科医院，以及社区外联计划。在上一学年，STC收治了735名创伤性脑损伤患者，其中250名被认为是重型(格拉斯哥昏迷评分3到8)，66名被认为是中度损伤(GCS 9到12)，147名年龄在21岁以下，382名非白人，176名女性，186名患者在系统内的两家康复医院之一出院。所有拟议的调查人员都是马里兰大学医学院的全职教员，自20世纪80年代中期以来，神经外科的成员几乎参与了每一项关于头部损伤的大型多中心研究，包括NIH创伤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，其作用是研究创伤的流行病学。正如意向书中规定的那样，应用程序将包括一项在多中心试验中研究治疗的概念方案。一旦资助期开始，拟议的减压开颅手术研究就可以在相对较短的时间内启动。虽然这一程序正在一些创伤中心进行，但具体的标准尚未确定，关于短期和长期结果的疗效尚不清楚。虽然这个概念过于简单化，但它的优点是有可能减轻脑肿胀，而不会出现血肿或挫伤，尽管继发性损伤的具体机制在损伤过程中的任何特定时间都是活跃的。

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.