Transfusion Medicine/Hemostasis Clinical Research Netwo*

输血医学/止血临床研究网络*

• 批准号: 6571692
• 负责人: DARRELL J TRIULZI
• 金额: $ 29.99万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6571692
• 关键词: adolescence (12-20); antithrombogenic surface; biomaterial interface interaction; blood disorder chemotherapy; blood transfusion; blood treatment; child (0-11); clinical research; clinical trials; cooperative study; drug screening /evaluation; hemophilia As; hemophilia B; hemostasis; human subject; human therapy evaluation; multiple organ failure; patient oriented research; plasminogen activator; thrombosis

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.

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）试图通过利用我们的三个优势来促进重要的多中心临床试验和止血的临床试验：1）彼得斯堡医学中心的综合大学（pittsburgh Attress withs aptals atters aptits aptits aptits apity forty forty forty forty forty forty forty forty forty forty）用于输血医学（ITXM）； 2）UPMCHS医院提供的非凡患者基础，包括匹兹堡癌症研究所（PCI），成人和小儿I级创伤中心，最大的器官移植计划，儿童医院，妇女医院，妇女医院以及包括西方PCI和PCI的血液友善中心在内3）所有三个核心中心研究人员在跑步和/或参加多中心的临床试验和止血的临床试验方面的丰富经验和外观。 具体目的：我们提出了两个方案来实现这些目标：1）激活酶在预防血友病中预防中心静脉通路装置感染中的前瞻性随机试验”（项目1）；和2）多中心，随机，随机，对照，血浆临床试验的临床试验，对群体相关的多个型多型型群体的临床及其对群的护理标准（项目2）的临床试验（项目2）。这些试验的实施和执行包括：每个协议的预算管理，及时建立计划网络办公室，协调每个协议的运行资源，例如，研究护士，数据文员），确保及时实施和操作新协议的及时实施和操作和出版物，建立一个社区咨询小组，以教育社区，讨论和传播研究结果，并与其他网络网站合作以选择和修改研究协议。