Traumatic Brain Injury Clinical Trials Network

描述（由申请人提供）：三十多年来，弗吉尼亚联邦大学医学院弗吉尼亚医院（VCU/MCVH）一直活跃于脑损伤研究，并为目前已知的脑损伤病理生理机制做出了贡献，并确立了早期积极神经外科干预的价值。外科技术的进步，颅内压的管理，以及急性护理管理的药理学方法帮助神经外科和VCU/MCVH作为一个研究和临床中心获得了国际认可。自20世纪70年代中期以来，物理医学和康复部（PM&R）与神经外科部门积极合作，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对长期结果的重要性。PM&R在过去十年中取得的进展包括建立统一的头部损伤数据库、扩展的护理系统、与服务提供者和倡导组织建立新的伙伴关系、验证改进的结果措施，以及与其他示范系统规划和数据库合作评估服务的成本、结果和效益。本申请是研究者响应RFA-HD-01-007作为临床网络站点参与合作协议。作为TBI网络的成员网站，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TBI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，他们包括了一个“概念方案”，简要概述了一项随机、安慰剂对照试验，以测试严重创伤性脑损伤患者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.