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Neurologic Emergencies Treatment Trials Network: Clinical Coordinating Center

神经急症治疗试验网络：临床协调中心

基本信息

批准号：
8914779
负责人：
WILLIAM G BARSAN
金额：
$ 45.36万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-01 至 2015-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8914779
关键词：
Academic Medical Centers Accident and Emergency department Acute Address Adherence Adult Agreement Ambulances Applications Grants Architecture Award Biometry Brain Brain Injuries Budgets Caring Case Report Form Childhood Clinical Clinical Investigator Clinical Trials Clinical Trials Design Clinical Trials Network Collaborations Coma Communication Communities Community Hospitals Continuing Education Contracts Country Data Development Discipline Disease Documentation Early Intervention Early treatment Economics Educational workshop Elements Emergency Department Physician Emergency Situation Emergency treatment Enrollment Ensure Environment Epidemiology Feedback Fostering Funding Future Goals Grant Hospitals Individual Information Networks Informed Consent Injury International Intervention Journals Leadership Manuscripts Medical Methods Michigan National Institute of Neurological Disorders and Stroke Nature Neurologic Neurological emergencies Neurologist Neurosurgeon Occupational activity of managing finances Online Systems Outcome Paramedical Personnel Patient Care Patient Recruitments Patients Peer Review Phase Phase III Clinical Trials Physicians Population Process Productivity Protocols documentation Publishing Recording of previous events Recruitment Activity Rehabilitation therapy Reporting Research Research Design Research Infrastructure Research Personnel Running Safety Schedule Science Seizures Site South Carolina Speed Spinal cord injury Staging Stroke Surgeon Surveys Symptoms System Time Translating Translational Research Translations Trauma U-Series Cooperative Agreements United States National Institutes of Health Universities Voice Work abstracting clinical practice data management data sharing design effective therapy expectation human subject improved innovation meetings multidisciplinary novel operation patient oriented patient population pragmatic trial pre-clinical research primary outcome programs sound statistical center success treatment trial

项目摘要

DESCRIPTION (provided by applicant): The overall goal of the Neurological Emergencies Treatment Trials (NETT) Network is to improve the outcomes of patients with acute neurological illness and injury by identifying effective treatments given in the earliest stages of care. In developing the NETT, the NINDS recognized that pre-clinical and translational research has demonstrated that there is a very narrow window of opportunity in which novel treatments for neurological emergencies are optimally effective, and that conducting research in the emergency setting presents unique pragmatic challenges to clinical investigators. Over the past four years, the NETT has proven to be a platform capable of selecting, developing, and simultaneously conducting multiple confirmatory clinical trials of very early interventions delivered in the ambulance or the emergency department (ED). The NETT has successfully competed for funding and implemented four actively enrolling clinical trials, two of which utilize exception from informed consent (EFIC), and one of which is already nearing completion. Several other trials are being developed with investigators from within as well as outside of the NETT. In all the trials initiated in NETT, subject accrual has been ahead of expectations and on budget. The successful operation can be attributed to the efficiency of the NETT organization and processes. The coordinating activities of the NETT are supported by two NINDS cooperative agreement grants to the Clinical Coordinating Center (CCC) at the University of Michigan (U01 NS056975) and the Statistical and Data Management Center (SDMC) in the Division of Biostatistics and Epidemiology (DBE) at the Medical University of South Carolina (U01 NS059041). In addition, 17 academic centers (Hubs) participate in the NETT with R01 grant support to each center from the NINDS. For the second five-year grant period, the CCC's aims are to maintain and enhance the collaborative relationships that form the NETT, develop trials that address important clinical questions, effectively disseminate and translate our findings, and continue to provide efficient project management for clinical trials to be conducted by the NETT. We will also explore innovations in clinical trial designs including adaptive study designs.

描述（由申请人提供）：神经系统紧急情况治疗试验（NETT）网络的总体目标是通过确定在护理的最早阶段给予的有效治疗来改善急性神经系统疾病和损伤患者的结局。在开发NETT的过程中，NINDS认识到，临床前和转化研究已经证明，对于神经系统紧急情况的新治疗方法具有最佳效果的机会窗口非常狭窄，并且在紧急情况下进行研究对临床研究人员提出了独特的务实挑战。在过去的四年中，NETT已被证明是一个平台，能够选择，开发，并同时进行多个验证性临床试验的非常早期的干预措施，在救护车或急诊科（艾德）。NETT已成功争取资金，并实施了四项积极招募的临床试验，其中两项利用知情同意例外（EFIC），其中一项已接近完成。其他几项试验正在与NETT内外的调查人员一起开发。在NETT启动的所有试验中，受试者累积均超出预期并在预算范围内。成功的运作可以归功于NETT组织和流程的效率。NETT的协调活动得到了两个NINDS合作协议的支持，分别是密歇根大学的临床协调中心（CCC）（U01 NS 056975）和南卡罗来纳州医科大学的生物统计学和流行病学（DBE）部的统计和数据管理中心（SDMC）（U01 NS 059041）。此外，17个学术中心（中心）参加了NETT，每个中心都得到了NINDS的R01资助。在第二个五年资助期内，中心的目标是维持和加强构成该小组的合作关系，发展针对重要临床问题的试验，有效地传播和翻译我们的研究结果，并继续为该小组进行的临床试验提供有效的项目管理。我们还将探索临床试验设计的创新，包括适应性研究设计。

项目成果

期刊论文数量（62）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

The 60-day temperature-dependent degradation of midazolam and Lorazepam in the prehospital environment.

DOI：
10.3109/10903127.2012.722177
发表时间：
2013-01
期刊：
Prehospital emergency care
影响因子：
2.4
作者：
McMullan JT;Pinnawin A;Jones E;Denninghoff K;Siewart N;Spaite DW;Zaleski E;Silbergleit R;Neurological Emergencies Treatment Trials investigators
通讯作者：
Neurological Emergencies Treatment Trials investigators

Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis.

DOI：
10.1186/s12910-015-0022-z
发表时间：
2015-05-03
期刊：
BMC medical ethics
影响因子：
2.7
作者：
Legocki LJ;Meurer WJ;Frederiksen S;Lewis RJ;Durkalski VL;Berry DA;Barsan WG;Fetters MD
通讯作者：
Fetters MD

The association of patient weight and dose of fosphenytoin, levetiracetam, and valproic acid with treatment success in status epilepticus.

DOI：
10.1111/epi.16534
发表时间：
2020-06
期刊：
Epilepsia
影响因子：
5.6
作者：
通讯作者：

Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage.

DOI：
10.1056/nejmoa1603460
发表时间：
2016-09-15
期刊：
The New England journal of medicine
影响因子：
0
作者：
Qureshi AI;Palesch YY;Barsan WG;Hanley DF;Hsu CY;Martin RL;Moy CS;Silbergleit R;Steiner T;Suarez JI;Toyoda K;Wang Y;Yamamoto H;Yoon BW;ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network
通讯作者：
ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network

Impact of presenting rhythm on short- and long-term neurologic outcome in comatose survivors of cardiac arrest treated with therapeutic hypothermia.

呈现节律对接受低温治疗的心脏骤停昏迷幸存者的短期和长期神经系统结果的影响。