Stanford University Hub for Neurological Emergency Treatment Trials

描述(申请人提供)：中风、癫痫、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急症，会导致严重的发病率和死亡率，并导致大量的人类痛苦和巨大的医疗费用。神经紧急情况可以是手术或非手术的，这一领域的临床试验需要一个由急诊医生、神经科医生、神经外科医生和神经强化医生组成的合作和协调的网络，他们可以协调院前、急诊科和医院内的环境，以确保神经紧急情况的临床试验能够有效实施。本提案是对网络枢纽站点的RFA-NS-06-009的响应，RFA-NS-06-002是NETT协调中心的RFA-NS-06-002的伙伴，本提案将描述我们将如何在该网络中作为枢纽与协调中心协作工作。该提案侧重于我们将如何利用我们作为院前、急诊和院内提供者的跨学科团队所拥有的独特技能、关系和经验，来招募、招募、治疗和跟踪患者，以便在我们的中心内的院前环境以及学术和社区医院为神经紧急情况患者进行拟议的临床试验。我们中心的第一个目标将是协调圣克拉拉县和圣马特奥县的2个EMS机构和7个学术和社区医院，其中3个还为圣克鲁斯县和圣贝尼托县提供创伤服务。这些医院和县急救机构提供了超过300,000次急救就诊，6,000次创伤激活和100,000次急救响应。我们中心的所有医院都通过建立需要认证或正在被认证为JACHO中风中心的方案和服务，展示了对神经紧急情况的承诺。第二个目标是利用斯坦福大学研究人员在急救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将如何与协调中心合作，在这些地点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，使用全天候支持以确保准确执行协议，并通过新的技术战略来跟踪和留住参加网络试验的患者来实现。

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.