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州钱德勒医学中心（UKCMC）重建神经系统紧急情况治疗试验（NETT）网络临床研究中心。该提案的总体目标是将UKCMC确定为一个学术医疗机构，其区域附属合作伙伴擅长“评估各种神经系统紧急情况患者的治疗”。“自2007年被竞争性地选为最初的17个网络站点之一以来，位于UKCMC（UK NETT）的NETT临床中心站点一直是NETT网络的积极参与者。在过去的4年中，作为参与临床中心，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（咪达唑仑与劳拉西泮治疗癫痫持续状态），ALIAS第2部分（白蛋白与安慰剂治疗急性缺血性卒中），POINT（氯吡格雷负荷预防短暂性脑缺血发作后卒中）和ProTECT（黄体酮与安慰剂在创伤性脑损伤中的比较）。急诊医学在该合资企业中有很好的代表性，因为最初和拟议的英国NETT位于UKCMC的急诊医学部。英国NETT是建立在机构内的合作，超越急诊医学，包括在神经科，神经外科，外科/创伤外科，麻醉/重症监护医学部门的医生教员。与英国NETT保持一致的区域附属医疗保健机构包括位于肯塔基州的“辐条”社区医院。提出了以下具体目的：1）证明在急性发作性神经系统疾病中进行的“大型、简单”临床试验中存在大量受试者招募的基础设施; 2）证明在急性发作性神经系统疾病中成功进行临床试验的经验，需要美国食品药品监督管理局规定的知情同意例外。

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.