Wake Forest Clinical Center for the NHLBI PETAL Network

描述(由申请人提供)：维克森林临床中心调查员将与维克森林临床中心(WFCC)、花瓣网络内的其他临床中心(CC)、临床协调中心(CCC)和NHLBI合作，并为其目标和运营做出贡献。拟议的工作将组织和管理在管理ALI患者和面临ALI风险的患者方面具有专业知识和领导能力的经验丰富的人员，包括危重护理、创伤、紧急普通外科和紧急医学，以满足RFA支持这一患者群体研究的要求。WFCC将能够很容易地实现RFA的长期目标和具体目标，包括4个独立的、具有积极的急诊医学和ICU研究能力的杰出研究机构。WFCC网站包括：维克森林大学健康科学(WFUHS)、弗吉尼亚大学健康系统(UVaHS)、摩西锥体健康系统(MCHS)和弗吉尼亚联邦健康系统(VCUHS)。WFCC将致力于进一步开发和支持临床试验的PEATAL方案，这些方案将影响有ALI风险的患者的结局。在申请中，我们提出了两个创新的方案(预防肺损伤的维生素C和减少ALI/ARDS幸存者再入院的出院后沟通干预)，供指导委员会审议，并承诺支持在拟议资助期内选择的所有积极方案。WFCC在ARDS网络I和II中的表现的跟踪记录表明，注册的科目数量高于我们的预测。重要的是，WFCC现在有了第四个新的站点，再次处于有利地位，可以在5.5年的试验登记期间满足或超过每年40名ALI高危患者或确诊的ALI/ARDS患者的登记要求，在整个资助期内至少有220名患者登记。招生目标将包括认识到需要解决重要人口群体内登记科目的分布问题。

DESCRIPTION (provided by applicant): The Wake Forest Clinical Center Investigators will collaborate with and contribute to the goals and operations of the Wake Forest Clinical Center (WFCC), other Clinical Centers (CC) within the PETAL Network, the Clinical Coordinating Center (CCC) and NHLBI. The work proposed will organize and manage experienced personnel with expertise and leadership in the management of patients with and at risk for ALI including critical care, trauma, emergency general surgery and emergency medicine, for the purposes of fulfilling the RFA's request to support research in this patient population. The WFCC will be readily able to meet the long-term objectives and specific aims of the RFA by inclusion of 4 separate, outstanding research institutions with active Emergency Medicine and ICU research capabilities. The WFCC sites include: Wake Forest University Health Sciences (WFUHS), the University of Virginia Health System (UVaHS), the Moses Cone Health Systems (MCHS)) and the Virginia Commonwealth Health System (VCUHS). The WFCC will work to further develop and support PETAL protocols for clinical trials that will impact the outcome of patients at risk fo and with established ALI. Within the application, we propose 2 innovative protocols (the Vitamin C to prevent lung injury and a novel post-hospital discharge communication intervention to reduce hospital readmissions in Survivors of ALI/ARDs) for consideration by the Steering Committee, and commit our support to all active protocols selected during the course of the proposed funding period. The track record of WFCC's performance in the ARDSnetwork I and II demonstrated an enrollment of subjects above our predictions. Importantly, the WFCC, now with a 4th new site, is again well positioned to meet or exceed the enrollment requirements of 40 subjects at risk for ALI or with established ALI/ARDS per year over the 5.5 year Trial enrollment period for a minimum total of 220 patients enrolled over the full duration of the grant's period. The enrollment objective will include recognition of the need to address the distribution of enrolled subjects within important demographic groups.