Transfusion Medicine/Hemostasis Clinical Research Network

输血医学/止血临床研究网络

• 批准号: 8136610
• 负责人: DARRELL J TRIULZI
• 金额: $ 16.24万
• 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 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8136610
• 关键词: Adult; Adverse event; Blood; Budgets; Cancer Center; Childhood; Clinical Research; Clinical Trials; Coagulation Process; Data; Data Analyses; Data Reporting; Enrollment; Faculty; Future; Health system; Hemophilia A; Hemostatic Agents; Hemostatic function; Hospitals; Institutes; Malignant Neoplasms; Medical center; Medicine; Nursing Research; Organ Transplantation; Outpatients; Patients; Pediatric Hospitals; Protocols documentation; Publications; Reporting; Research; Research Infrastructure; Research Personnel; Resources; Running; Services; Site; Transfusion; Universities; University Hospitals; Woman; Work; base; evidence based guidelines; experience; follow-up; granulocyte; meetings; member; operation; programs; trauma centers

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.

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）； TMH网络的原始和活跃成员试图继续为输血医学和止血的重要多中心临床试验做出贡献。我们在成功执行第一项TMH研究（PLADO）方面已经利用了我们的三项优势，并将这些优势应用于TMH网络进行的未来试验。这些优势包括：1）匹兹堡大学输血医学研究所（ITXM）的匹兹堡医学中心卫生系统（UPMCHS）医院的输血医学和凝结服务的综合交付。 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，大型器官移植计划，儿童医院，妇女医院以及门诊设施，包括全面的血友病中心和癌症中心。 3）研究人员和研究协调员在跑步和/或参加输血医学和止血的多中心临床试验方面的丰富经验。具体目的：核心中心将提供成功实施和执行这些试验所必需的基础架构和监督，包括：每种协议的预算管理，使用我们既定的计划网络办公室的行政支持，管理资源的管理协调每个协议（例如，研究护士，数据经理，数据经理）的协议，确保及时的协议，通过新的协议来实施新协议，以实施新的协议（例如，量身定期的研究，请随访，数据，数据，数据，数据，），数据，数据，数据，），数据，数据，），数据，），），），数据，），数据，），），数据，），数据，），），）不良事件报告，数据分析，解释和出版的研究人员，并与其他网络站点合作以选择和修改研究协议。我们将通过完成计划的PLADO研究，启动船舶研究并实施即将进行的TMH临床研究，包括但不限于Rich，CVAD，CVAD，颗粒细胞和明星，实现了这些目标。预计这些临床研究将提供至关重要的信息，以建立基于证据的建议，以治疗需要血液成分或患有止血异常的患者。

项目成果

Effects of red-cell storage duration on patients undergoing cardiac surgery.

• DOI: 10.1056/nejmoa1414219
• 发表时间: 2015-04-09
• 期刊: The New England journal of medicine
• 作者: Steiner ME;Ness PM;Assmann SF;Triulzi DJ;Sloan SR;Delaney M;Granger S;Bennett-Guerrero E;Blajchman MA;Scavo V;Carson JL;Levy JH;Whitman G;D'Andrea P;Pulkrabek S;Ortel TL;Bornikova L;Raife T;Puca KE;Kaufman RM;Nuttall GA;Young PP;Youssef S;Engelman R;Greilich PE;Miles R;Josephson CD;Bracey A;Cooke R;McCullough J;Hunsaker R;Uhl L;McFarland JG;Park Y;Cushing MM;Klodell CT;Karanam R;Roberts PR;Dyke C;Hod EA;Stowell CP
• 通讯作者: Stowell CP