Neurologic Emergencies Treatment Trials Network: Clinical Coordinating Center

神经急症治疗试验网络：临床协调中心

• 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
• 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

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）：神经急症治疗试验 (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疾病和损伤患者的治疗结果。在制定 NINDS 时，NINDS 认识到，临床前和转化研究已表明，神经紧急情况的新疗法发挥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神经系统紧急情况的研究提出了独特的务实挑战。临床研究者。在过去的四年里，NETT 已被证明是一个能够选择、开发并同时对救护车或急诊科 (ED) 中提供的早期干预措施进行多项验证性临床试验的平台。 NETT 已成功竞争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。 NTT 内部和外部的研究人员正在开发其他几项试验。在 NTT 发起的所有试验中，受试者的增长均超出预期且符合预算。成功的运作归功于NETT组织和流程的效率。 NETT 的协调活动得到了两项 NINDS 合作协议拨款的支持，该协议拨款给密歇根大学临床协调中心 (CCC) (U01 NS056975) 和生物统计和流行病学部 (DBE) 统计和数据管理中心 (SDMC) ）在南卡罗来纳医科大学（U01 NS059041）。此外，还有 17 个学术中心（中心）参与了 NETT，并获得 NINDS 向每个中心提供 R01 拨款支持。在第二个五年资助期内，CCC 的目标是维持和加强形成 NETT 的合作关系，开发解决重要临床问题的试验，有效传播和转化我们的研究结果，并继续为临床试验提供高效的项目管理由NETT 进行。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

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

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

Management of refractory status epilepticus in adults: still more questions than answers.

• DOI: 10.1016/s1474-4422(11)70187-9
• 发表时间: 2011-10
• 期刊: LANCET NEUROLOGY
• 影响因子: 48
• 作者: Rossetti, Andrea O.;Lowenstein, Daniel H.
• 通讯作者: Lowenstein, Daniel H.

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
• 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