Wake Forest Clinical Center for the NHLBI PETAL Network

描述（由申请人提供）：维克森林临床中心研究者将与维克森林临床中心（WFCC）、PETAL网络内的其他临床中心（CC）、临床协调中心（CCC）和NHLBI合作，并为这些中心的目标和运营做出贡献。拟议的工作将组织和管理经验丰富的人员，这些人员在管理ALI患者和存在ALI风险的患者方面具有专业知识和领导能力，包括重症监护、创伤、急诊普通外科和急诊医学，以满足RFA支持该患者人群研究的要求。WFCC将通过纳入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，随时能够满足RFA的长期目标和具体目标。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PETAL临床试验方案，这些方案将影响有急性肺损伤风险和已确诊急性肺损伤患者的结局。在申请中，我们提出了两项创新方案（预防肺损伤的维生素C和减少ALI/ARDs幸存者再入院的新型出院后沟通干预）供指导委员会审议，并承诺支持在拟议资助期间选择的所有积极方案。WFCC在ARDSnetwork I和II中的表现的跟踪记录表明，受试者的入学率高于我们的预测。重要的是，WFCC现在有了第四个新的研究中心，再次有能力满足或超过在5.5年的试验入组期内每年40例有ALI风险或确诊的ALI/ARDS受试者的入组要求，在整个资助期内至少共入组220例患者。入组目标将包括认识到需要解决入组受试者在重要人口统计学人群中的分布。

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.