Wake Forest Clinical Center for the NHLBI PETAL Network

NHLBI PETAL 网络维克森林临床中心

基本信息

批准号：
8874287
负责人：
Daniel Clark Files
金额：
$ 30.14万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-06-17 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8874287
关键词：
Accident and Emergency department Acute Acute Lung Injury Address Adult Respiratory Distress Syndrome Ascorbic Acid Baptist Church Burn injury Center for Translational Science Activities Clinical Clinical Research Clinical Trials Clinical trial protocol document Collaborations Communication Communities Community Hospitals Conduct Clinical Trials Cone Critical Care Critical Illness Department of Defense Development Early Intervention Early treatment Emergency Medicine Emergency Situation Enrollment Environment Faculty Funding Goals Grant Health Health Sciences Health system Hospitals Human Resources Infusion procedures Injury Institution Interdisciplinary Study Intervention Leadership Link Lung Medical center Multicenter Studies National Heart, Lung, and Blood Institute Operative Surgical Procedures Outcome Participant Patients Performance Positioning Attribute Prevention Principal Investigator Private Practice Procedures Protocols documentation Recording of previous events Research Research Personnel Research Support Resources Risk Role Seasons Services Site Structure Suggestion Survivors Trauma United States National Institutes of Health Universities Virginia Work Writing design experience follow-up forest hospital readmission improved innovation lung injury meetings novel operation patient population prevent trial design

项目摘要

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.

描述（由申请人提供）：维克森林临床中心研究人员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) 合作并为实现其目标和运营做出贡献) 和 NHLBI。拟议的工作将组织和管理经验丰富的人员，这些人员在 ALI 患者和有 ALI 风险的患者管理方面具有专业知识和领导力，包括重症监护、创伤、急诊普通外科和急诊医学，以满足 RFA 支持这方面研究的要求。患者群体。通过纳入 4 个独立的、具有活跃急诊医学和 ICU 研究能力的杰出研究机构，WFCC 将能够轻松实现 RFA 的长期目标和具体目标。 WFCC 站点包括：维克森林大学健康科学系统 (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用于临床试验的 PETAL 方案，这将影响有 ALI 风险和已确诊 ALI 的患者的结果。在申请中，我们提出了 2 项创新方案（预防肺损伤的维生素 C 和减少 ALI/ARD 幸存者再入院的新型出院后沟通干预措施）供指导委员会考虑，并承诺为所有各方提供支持在拟议资助期间选择的有效协议。 WFCC 在 ARDSnetwork I 和 II 中的表现记录表明，受试者的注册人数超出了我们的预测。重要的是，WFCC 现已拥有第四个新站点，再次处于有利地位，可以在 5.5 年试验注册期内每年满足或超过 40 名有 ALI 风险或患有 ALI/ARDS 的受试者的注册要求，至少总共在整个资助期内，共有 220 名患者入组。注册目标将包括认识到需要解决注册受试者在重要人口群体中的分布问题。