Stanford University Hub for Neurological Emergency Treatment Trials

描述（由申请人提供）：中风、癫痫发作、脑膜炎、缺氧性脑损伤、创伤性脑损伤、脊髓损伤和脑出血是常见的神经系统急症，可导致显著的发病率和死亡率，并导致严重的人类痛苦和巨大的医疗保健费用。神经系统紧急情况可以是手术或非手术，该领域的临床试验需要急诊医生、神经科医生、神经外科医生和神经重症监护医师的合作和协调网络，他们可以协调院前、急诊科和院内环境，以确保神经系统紧急情况的临床试验能够有效实施。本建议书是对网络中心站点RFA-NS-06-009的回应，该建议书是NETT协调中心RFA-NS-06-002的配套文件，本建议书将描述我们将如何作为网络中的中心与协调中心协作。该提案的重点是我们将如何利用我们作为院前、急诊和住院提供者的跨学科团队所拥有的独特技能、关系和经验，在院前环境以及我们中心内的学术和社区医院招募、登记、治疗和随访患者，以进行针对神经系统急诊患者的拟议临床试验。我们中心的第一个目标是协调圣克拉拉和圣马特奥县的2个EMS机构和7个学术和社区医院，其中3个还为圣克鲁斯和圣贝尼托县提供创伤服务。这些医院和县EMS机构占超过300，000次艾德就诊，6，000次创伤激活和100，000次EMS响应。我们中心的所有医院都通过制定协议和服务来证明对神经系统紧急情况的承诺，这些协议和服务将被认证或正在被认证为JACHO卒中中心。第二个目标是利用斯坦福大学研究人员在急诊医学和神经学研究方面的专业知识，将他们的临床研究基础设施和经验扩展到中心内的所有地点。第三个目标是描述中心如何与协调中心合作，在这些研究中心实施临床试验基础设施。这将通过与EMS提供商合作，使用创新系统来识别潜在患者，使用24/7随叫随到支持来确保方案的准确实施，并使用新的技术策略来随访和保留进入网络试验的患者。

DESCRIPTION (provided by applicant): Stroke, seizures, meningitis, anoxic brain injury, traumatic brain injury, spinal cord injury and intracerebral hemorrhage are common neurological emergencies that cause significant morbidity and mortality and result in substantial human suffering and enormous health care costs. Neurological emergencies can be surgical or non-surgical and clinical trials in this area requires a cooperative and coordinated network of emergency physicians, neurologists, neurosurgeons and neurointensivists who can coordinate the pre-hospital, emergency department and inhospital environments to ensure clinical trials for neurological emergencies can be effectively implemented. This proposal, in response to RFA-NS-06-009 for the network hub sites which is a companion to RFA-NS-06-002 for the NETT coordinating center, will describe how we will function as a hub in this network to work in collaboration with the coordinating center. The proposal focuses on how we will utilize the unique skills, relationships and experiences we have as an interdisciplinary team of pre- hospital, emergency and in-hospital providers to recruit, enroll, treat and follow-up patients for proposed clinical trials for patients with neurological emergencies in the pre-hospital environment and at academic and community hospitals within our hub. The first aim of our hub will be to coordinate 2 EMS agencies and seven academic and community hospitals in Santa Clara and San Mateo counties, of which three also provide trauma services to Santa Cruz and San Benito counties. These hospitals and county EMS agencies accounted for over 300,000 ED visits, 6,000 trauma activations and 100,000 EMS responses. All hospitals in our hub have demonstrated a commitment to neurological emergencies by instituting protocols and services to be accredited or in the process of being accredited as JACHO stroke centers. The second aim will be to utilize the expertise of the investigators from Stanford University in emergency medicine and neurological research to extend their clinical research infrastructure and experience to all sites within the hub. The third aim will be to describe how the hub will work with the coordinating center to implement clinical trial infrastructure at these sites. This will be done by partnering with the EMS providers, using innovative systems to identify potential patients, using 24/7 on call support to ensure accurate implementation of protocols and with novel technology strategies to follow-up and retain patients entered into network trials.