UK NETT Clinical Site Hub

英国 NTT 临床站点中心

基本信息

批准号：
8715869
负责人：
Roger Loyd Humphries
金额：
$ 26.99万
依托单位：
UNIVERSITY OF KENTUCKY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-05-03 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8715869
关键词：
Accident and Emergency department Acute Affect Air Albumins Ambulances American Anesthesiology Area Beds Brain Caring Cause of Death Clinical Clinical Research Clinical Trials Collaborations Communities Community Hospitals Conduct Clinical Trials Disease Emergency Medicine Emergency treatment Enrollment Evaluation Faculty Goals Grant Healthcare Hospitals Human Individual Informed Consent Intensive Care Internet Ischemic Stroke Kentucky Lorazepam Medical Medical center Medicine Midazolam Modeling National Institute of Neurological Disorders and Stroke Nervous system structure Network-based Neurological emergencies Neurology Operative Surgical Procedures Participant Patients Pharmacists Phase Phase III Clinical Trials Physicians Placebos Positioning Attribute Progesterone Progress Reports Public Health Recruitment Activity Regulation Research Research Infrastructure Resources Rural Seizures Services Site Source Speed Spinal cord injury Status Epilepticus Stream Stroke Stroke prevention Telecommunications Transient Ischemic Attack Trauma Traumatic Brain Injury United States Dept. of Health and Human Services United States Food and Drug Administration United States National Institutes of Health Universities Urban Population base clinical research site clopidogrel disability experience high risk meetings member nervous system disorder neurosurgery programs response square foot success trauma centers treatment trial

项目摘要

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.

描述（由申请人提供）：该提案描述了在肯塔基州列克星敦的肯塔基大学钱德勒医学中心 (UKCMC) 重建神经急症治疗试验 (NETT) 网络临床站点中心，以响应 NIH/NINDS PAR -11-342。该提案的总体目标是将 UKCMC 确定为学术医疗机构，其区域附属合作伙伴擅长“对患有广泛神经系统紧急情况的患者进行治疗评估”。 UKCMC 的 NETT 临床中心站点（UK NETT）自 2007 年被竞争性地选为最初的 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 4 年里，作为参与临床中心站点，UK NetT 已在 NETT 网络内进行的 111 期临床试验中招募了 50 多名受试者，其中包括 RAMPART（咪达唑仑与劳拉西泮治疗癫痫持续状态）， ALIAS 第 2 部分（急性缺血性中风中的白蛋白与安慰剂）、POINT（短暂性脑缺血发作后预防中风的氯吡格雷负荷）和 ProTECT（创伤性脑损伤中的黄体酮与安慰剂）。急诊医学在该合资企业中得到了很好的体现，因为最初和拟议的 UK NET 均设在 UKCMC 的急诊医学部内。 UK NETT 建立在机构内部合作的基础上，合作范围不仅限于急诊医学，还包括神经内科、神经外科、外科/创伤外科和麻醉科/重症监护医学科的医师教员。与 UK NTT 合作的地区附属医疗机构包括位于肯塔基州的“辐射”社区医院。提出以下具体目标： 1) 证明在急性发作的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，以及 2) 证明在急性发作的神经系统疾病中成功进行临床试验的经验- 发生神经系统疾病，需要美国食品和药物管理局规定的知情同意例外。