Preventive and Early Treatment of Acute Lung Injury Clinical Trials Network- Pgh

描述（由申请人提供）：匹兹堡大学寻求加入PETAL网络，宾夕法尼亚州立大学好时医学中心作为我们的卫星合作伙伴。我们的目标是作为一个临床中心全面参与PETAL网络，共同的使命是为那些患有或有急性肺损伤（ALI）或急性呼吸窘迫综合征（ARDS）风险的人实现更好的理解、治疗和结果。我们已经组建了一支由资深思想领袖和有才华的研究人员组成的团队，他们在ALI/ARDS相关的基础、转化、临床和结果研究方面具有专业知识。

DESCRIPTION (provided by applicant): The University of Pittsburgh seeks to join the PETAL network, with Penn State University Hershey Medical Center as our satellite partner. Our goal is to participate fully in the PETAL network as a Clinical Center, with the shared mission of achieving better understanding, treatment, and outcomes for those with or at risk for acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). We have assembled a team of senior thought leaders and talented investigators with expertise in basic, translational, clinical and outcomes research relevant to ALI/ARDS. We detail the qualifications of our dual PIs, presenting evidence for their ability to work as a pat of the network leadership in defining work, operational solutions needed, future opportunities, and creation of material to share the scientific results for PETAL research efforts. We next note the features that allow our clinical center to successfully participate, including meeting enrollment needs and doing so in key and early care sites. Our clinical center proposes two interventional studies for PETAL evaluation and implementation: A trial of nebulized DNAase as an ARDS-prevention strategy; and trial of protocolized neuromuscular blockade as an ARDS early treatment strategy. We describe the scientific background, key features of each intervention, present our plans that include clinical outcome assessment and focused biomarker collection, and consider threats and contingencies where applicable. We also describe our research and clinical environments, IRB support, procedures to ensure appropriate human subjects protection, to obtain and manage all data and biospecimens with appropriate security, to comply with all training and regulatory requirements, and to maintain local structured oversight to ensure optimal participation within the network.