Transfusion Medicine/Hemostasis Clinical Research Network

描述(由申请人提供) 核心中心计划目标：匹兹堡输血医学/止血研究网络(PTN)作为TMH网络的原始和活跃成员，寻求继续为输血医学和止血方面的重要多中心临床试验做出贡献。我们已经利用我们的三个优势成功地执行了第一项TMH研究(PLADO)，并将以类似的方式将这些优势应用于TMH网络将进行的未来试验。这些优势包括：1)匹兹堡大学输血医学研究所(ITxM)的匹兹堡大学教员为匹兹堡大学医疗中心健康系统(UPMCHS)的所有主要医院提供综合的输血药物和凝血服务。2)UPMCHS医院提供非凡的病人基础，包括匹兹堡癌症研究所(PCI)、成人和儿科I级创伤中心、大型器官移植计划、儿童医院、妇女医院和包括综合血友病中心和癌症中心在内的门诊设施。3)研究人员和研究协调员在运行和/或参与输液药物和止血的多中心临床试验方面具有丰富的经验。具体目标：核心中心将为这些试验的成功实施和执行提供必要的基础设施和监督，包括：管理每个方案的预算，利用我们建立的计划网络办公室提供行政支持，协调每个方案运行的资源(如研究护士、数据经理)，确保新方案的及时实施和运行(如应计、数据报告、患者随访)，通过与方案调查人员的定期研究会议提供监督，协助方案调查人员进行不良事件报告、数据分析、解释和发布，并与其他网络站点合作选择和修订研究方案。我们将通过完成PLADO研究的计划登记，启动SHIP研究的登记，以及实施即将到来的TMH临床研究，包括但不限于RICH、CVAD、粒细胞和STAR来实现这些目标。预计这些临床研究将提供为需要血液成分的患者或止血异常患者的治疗建立基于证据的建议所需的至关重要的信息。 匹兹堡大学评论

DESCRIPTION (provided by applicant) Core Center Program Objectives: The Pittsburgh Transfusion Medicine/Hemostasis Research Network (PTN); an original and active member of the TMH network seeks to continue to contribute to important multicenter clinical trials in transfusion medicine and hemostasis. We have capitalized on our three strengths in successfully executing the first TMH study (PLADO) and will apply these strengths similarly to t future trials to be conducted by the TMH network. These strengths include: 1) The integrated delivery of transfusion medicine and coagulation services to all the major University of Pittsburgh Medical Center Health System (UPMCHS) hospitals by the University of Pittsburgh faculty at the Institute For Transfusion Medicine (ITxM). 2) The extraordinary patient base afforded by the UPMCHS hospitals including a Pittsburgh Cancer Institute (PCI), adult and pediatric level I trauma centers, a large organ transplant program, a children's hospital, a women's hospital and outpatient facilities including a comprehensive hemophilia center and cancer center. 3) The extensive experience of the investigators and study coordinator in running and/or participating in multicenter clinical trials in transfusion medicine and hemostasis. Specific Aims: The Core Center will provide the infrastructure and oversight necessary for the successful implementation and execution of these trials including: management of the budget for each protocol, administrative support using our established program network office, coordination of resources for the operation of each protocol (eg research nurse, data manager), assure timely implementation and operation of new protocols (eg accrual, data reporting, patient follow up), provide oversight through regular research meetings with protocol investigators, assist protocol investigators with adverse event reporting, data analysis, interpretation, and publication, and work with other network sites to select and revise study protocols. We will meet these objectives by completing our planned enrollment of the PLADO study, initiating enrollment in the SHIP study, and implementing the upcoming TMH clinical studies including but not limited to RICH, CVAD, Granulocyte and STAR. These clinical studies are expected to provide critically important information needed to establish evidence based recommendations for the treatment of patients requiring blood components or patients with hemostatic abnormalities. UNIVERSITY OF PITTSBURGH CRITIQUES