Transfusion Medicine/Hemostasis Clinical Research Netwo*

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)寻求通过利用我们的三个优势为输血医学和止血方面的重要多中心临床试验做出贡献：1)匹兹堡大学输血医学研究所(ITxM)的匹兹堡大学教员向匹兹堡大学医学中心卫生系统(UPMCHS)所有主要医院提供综合输血药物和凝血服务；2)UPMCHS医院包括匹兹堡癌症研究所(PCI)、成人和儿科I级创伤中心、最大的器官移植项目、儿童医院、妇女医院和门诊设施(包括西宾夕法尼亚大学血友病中心和PCI)提供的非凡患者基础；以及3)所有三家核心中心研究人员在运行和/或参与输血药物和止血方面的多中心临床试验方面的丰富经验和专业知识。 具体目标：我们提出了两个方案来实现这些目标：1)活化酶预防血友病中心静脉通路感染的前瞻性随机试验(方案1)；和2)多中心、随机、对照的血浆置换治疗儿童血小板减少相关性多器官衰竭的临床试验(项目2)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，及时建立方案网络办公室，协调每个方案运行的资源(例如，研究护士，数据职员)，通过与方案调查人员的两周研究会议，确保新方案的及时实施和运行(例如，及时的数据报告，患者随访)，为每个方案建立一个当地的DSMB，协助方案调查人员进行数据分析、解释和发布，建立社区咨询小组以教育社区并讨论和传播研究结果，并与其他网络站点合作选择和修改研究方案。

DESCRIPTION (provided by applicant): Core Center Program Objectives: The Pittsburgh Transfusion Medicine/Hemostasis Research Network (PTN) seeks to contribute to important multicenter clinical trials in transfusion medicine and hemostasis by capitalizing on our three strengths: 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 largest organ transplant program, a children's hospital, a women's hospital and outpatient facilities including the Hemophilia Center of Western PA and PCI; and3) The extensive experience and extertice of all three core center investigators in running and/or participating in multicenter clinical trials in transfusion medicine and hemostasis. Specific Aims: We propose two protocols to accomplish these objectives:1) Prospective Randomized Trial of Activase in the Prevention of Central Venous Access Device Infection in Hemophilia" (Project 1); and2) Multi-center, Randomized, Controlled Clinical Trial of Plasma Exchange Therapy vs Standard of Care in Children with Thrombocytopenia Associated Multi-Organ Failure (Project 2)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, timely establishment of program network office, coordinate resources for the operation of each protocol (e.g., research nurse, data clerk), assure timely implementation and operation of new protocols (e.g., accrural, timely data reporting, patient follow up) through biweekly research meetings with protocol investigators, establish a local DSMB for each protocol, assist protocol investigators with data analysis, interpretation, and publication, establish a Community Advisory Group to educate the community and to discuss and disseminate study results, and work with other network sites to select and revise study protocols.