Clinical Trials Network Site

描述(申请人提供)：三十多年来，弗吉尼亚联邦大学弗吉尼亚医院医学院(VCU/MCVH)一直活跃在脑损伤的研究中，对目前已知的脑损伤的病理生理机制做出了贡献，并确立了早期、积极的神经外科干预的价值。外科技术、颅内压管理和急性护理管理的药理学方法的进步帮助神经外科和VCU/MCVH获得了作为研究和临床中心的国际认可。自20世纪70年代中期以来，物理医学和康复系(PM&R)一直与神经外科积极合作，开发创新的跨学科方法，为创伤性脑损伤(TBI)患者提供最佳护理。这些合作证明了早期治疗决定长期结果的重要性。PM&R在过去十年中取得的进展包括创建统一的头部损伤数据库、扩展的护理系统、与服务提供商和倡导组织建立新的伙伴关系、验证改进的结果衡量标准，以及在评估服务的成本、结果和好处方面与其他模型系统计划和数据库合作。这项申请是研究人员对RFA-HD-01-007的响应，根据合作协议作为临床网络站点参与。作为创伤性脑损伤网络的成员，他们将与其他成员、数据协调中心和国家儿童健康与人类发展研究所的项目科学家合作，为中度或重度创伤性脑损伤患者制定、实施和评估研究方案、干预措施和评估策略。按照RFA的要求，他们已经包括了一项“概念方案”，其中简要概述了一项随机、安慰剂对照试验，以测试在严重脑外伤患者中单次静脉输注环孢素A的安全性、耐受性和药代动力学。

DESCRIPTION (provided by applicant): For over thirty years, the Virginia Commonwealth University's Medical College of Virginia Hospital (VCU/MCVH) has been active in brain injury research and has contributed to what is now known about its pathophysiological mechanisms and established the value of early, aggressive neurosurgical intervention. Advances in surgical techniques, management of intracranial pressure, and pharmacological approaches to acute care management helped the Division of Neurosurgery and VCU/MCVH attain international recognition as a research and clinical center. Since the mid-1970s, the Department of Physical Medicine and Rehabilitation (PM&R) has collaborated actively with the Division of Neurosurgery to develop innovative, interdisciplinary approaches to providing optimal care to patients with a traumatic brain injury (TBI). These collaborations have demonstrated the importance of early treatment decisions on long-term outcome. Advances made in the past decade by PM&R include the creation of a uniform head injury database, an extended system of care, new partnerships with service providers and advocacy organizations, validation of improved outcome measures, and collaboration with other model systems programs and databases in evaluating the costs, outcomes, and benefits of service. This application is the investigators' response to RFA-HD-01-007 to participate under a cooperative agreement as a Clinical Network Site. As a member site of the TBI Network, they will collaborate with other members, the Data Coordinating Center and project scientists of the National Institute of Child Health and Human Development to develop, implement, and assess research protocols, interventions, and evaluation strategies for patients with a moderate or severe TBI. As requested in the RFA, they have included a "concept protocol" which briefly outlines a randomized, placebo-controlled trial to test the safety, tolerability, and pharmacokinetics of a single intravenous infusion of Cyclosporin A in patients with a severe TBI.