UK NETT Clinical Site Hub

描述(由申请人提供)：本提案描述了根据NIH/NINDS PAR-11-342，在肯塔基州列克星敦的肯塔基大学钱德勒医学中心(UKCMC)重建神经紧急情况治疗试验(NETT)网络临床站点中心。这项提案的总体目标是将UKCMC确定为一个学术医疗机构，并与地区附属伙伴合作，擅长“评估患有广泛神经紧急情况的患者的治疗”。位于英国NETT中心的NETT临床中心站点自2007年被选为最初的17个网络站点之一以来，一直是NETT网络的积极参与者。在过去四年中，作为临床中心网站的参与，英国NETT在NETT网络内进行的111期临床试验中招募了50多名受试者，包括Rampart(咪达唑仑与劳拉西潘在癫痫持续状态中的对比)、别名第二部分(白蛋白与安慰剂在急性缺血性中风中的对比)、POINT(氯吡格雷负荷用于短暂性脑缺血发作后的卒中预防)和Protect(黄体酮与安慰剂在创伤性脑损伤中的对比)。急诊医学在这一合资企业中得到了很好的代表，因为最初和拟议的英国NETT是在UKCMC的急诊医学部内。英国NETT建立在机构内部合作的基础上，这种合作超越了急诊医学，包括神经外科、神经外科、外科/创伤外科和麻醉学/重症监护医学系的内科教员。与英国NETT结盟的地区性附属医疗机构包括位于肯塔基州的“分支”社区医院。建议的具体目标如下：1)证明在急性起病神经障碍的“大型、简单”临床试验中存在大量受试者招募的基础设施；2)证明成功地进行急性起病神经障碍临床试验的经验，根据美国食品和药物管理局的规定，这些临床试验需要获得知情同意的例外。

DESCRIPTION (provided by applicant): This proposal describes the re-establishment of a Neurological Emergencies Treatment Trials (NETT) Network Clinical Site Hub at the University of Kentucky Chandler Medical Center (UKCMC) in Lexington, Kentucky, in response to NIH/NINDS PAR-11-342. The overall goal of this proposal is to identify UKCMC as an academic medical facility with regional affiliate partners adept in "the evaluation of treatments for patiens with a broad spectrum of neurological emergencies." The NETT Clinical Hub Site at UKCMC (UK NETT) has been a vigorous participant in the NETT Network since its competitive selection as one of the original 17 Network sites in 2007. During the past 4 years as a participating Clinical Hub Site, UK NETT has enrolled more than 50 subjects in the Phase 111 clinical trials undertaken within the NETT Network, to include RAMPART (midazolam v. lorazepam in status epilepticus), ALIAS Part 2 (albumin v. placebo in acute ischemic stroke), POINT (clopidogrel loading for stroke prevention after transient ischemic attack), and ProTECT (progesterone v. placebo in traumatic brain injury). Emergency Medicine is well represented within this venture, as the original and proposed UK NETT are based within the Department of Emergency Medicine at UKCMC. UK NETT is founded upon an intra-institutional collaboration that extends beyond Emergency Medicine to include physician faculty members in the Departments of Neurology, Neurosurgery, Surgery/Trauma Surgery, and Anesthesiology/Intensive Care Medicine. Regional affiliate medical care facilities aligned with UK NETT include "spoke" community hospitals located within Kentucky. The following Specific Aims are proposed: 1) To demonstrate the existence of an infrastructure for high-volume subject recruitment in "large, simple" clinical trials performed in acute-onset neurological disorders and 2) To demonstrate experience in successfully conducting clinical trials in acute-onset neurological disorders, requiring Exception from Informed Consent as regulated by the United States Food & Drug Administration.