TMH Clinical Trials Network-Wisconsin Core Clinical Center

TMH 临床试验网络-威斯康星州核心临床中心

• 批准号: 8137717
• 负责人: JANICE G MC FARLAND
• 金额: $ 19.54万
• 依托单位: VERSITI WISCONSIN, INC.
• 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/8137717
• 关键词: Address; Area; Award; Blood Component Removal; Blood Platelets; Clinical; Clinical Trials; Clinical Trials Network; Disease; Dose; Enrollment; Funding; Gills; Hemophilia A; Hemorrhage; Hemostatic function; Hospitals; Infection; Institutional Review Boards; Medicine; Neutropenia; Participant; Patients; Procedures; Protocols documentation; Publications; Randomized Clinical Trials; Research Personnel; Services; Site; System; Teaching Hospitals; Thromboembolism; Time; Training Support; Transfusion; Universities; Wisconsin; granulocyte; inhibitor/antagonist; neoplastic; prevent; prophylactic; response; rituximab; success

DESCRIPTION (provided by applicant) Project Summary: BloodCenter of Wisconsin (BCW) together with its consortium partner, the University of Wisconsin (UW) were awarded Core Clinical Center (CCC) status when the Transfusion Medicine and Hemostasis (TMH) Clinical Trial Network (CTN) began in 2002. Wisconsin TMH investigators have been active participants in Network activities over the initial 5 years of funding, helping to develop trials in several of the key areas being addressed by the Network and enrolling patients in the first approved Network study - "Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients" or PLADO. This proposal is to continue our CCC's participation in the TMH-CTN over the next 5 years, helping to build on and implement additional clinical trials in these areas of medicine. Specifically, we propose to: 1) Continue our participation in the TMH-CTN trials that have been activated so far (PLADO, "Study of Hemostasis and Invasive Procedures" (SHIP), and "Rituximab for the treatment of Inhibitors in Congenital Hemophilia A" (RICH)) and to add to these, new trials as they are approved (e.g. "Pipeline" trials: "HIT Observational Thromboembolism Study" (HOT), "Study of TTP and Rituximab: A Randomized Clinical Trial" (STAR) and "High Dose Granulocyte Transfusions for the Treatment of Infections in Neutropenia" (the Granulocyte Trial)) and others as they are developed and approved. 2) Participate actively in the Network Steering Committee and Sub-Committee activities in proposing, developing and bringing to Network approval, additional relevant studies in the areas of hemostasis and transfusion medicine 3) Develop collaborative relationships and support training opportunities to facilitate the success of the proposed clinical trials and further the fields of transfusion medicine and hemostasis. 4) Together with TMH Colleagues, disseminate results of the TMH CTN through presentation and publication of clinical trial results and other TMH-CTN activities. Relevance: We believe that the trials developed to date all address important questions in transfusion medicine and hemostasis that required Network participation to be successful. This is in keeping with both the original RFA proposal and the stated objectives of the RFA for continuation of the TMH-CTN.

描述（由申请人提供） 项目摘要：威斯康星州（BCW）的血液中心以及其财团合作伙伴威斯康星大学（UW）被授予核心临床中心（CCC）地位，当时输血医学和止血和止血（TMH）临床试验网络（CTN）于2002年开始了一些竞争者，该活动的活动是在2002年开始的，该活动的活动是在2002年开始的。由网络和患者参加首次批准的网络研究：“确定最佳预防性血小板剂量策略，以防止血小板减少患者出血”或PLADO。该建议是在未来5年内继续我们的CCC参与TMH-CTN，有助于在这些医学领域建立和实施其他临床试验。具体而言，我们建议：1）继续我们参与到目前为止已激活的TMH-CTN试验（Plado，“研究止血和入侵程序的研究”（船）（船）和“利妥昔单抗治疗先天性血友病中的抑制剂，用于先天性血友病A”（RICH）），并添加到这些试验中。血栓栓塞研究“（HOT），TTP和利妥昔单抗研究：一项随机临床试验”（Star）和“高剂量粒细胞输血，用于治疗中性粒细胞减少症中的感染”（颗粒细胞试验），以及其他人在开发和批准的情况下进行。 2）积极参与网络指导委员会和小组委员会活动，在止血和输血医学领域提出，开发和带来网络批准，其他相关研究3）建立了协作关系，并支持培训机会，以促进拟议的临床试验的成功，并进一步进一步的输血医学和疾病。 4）与TMH同事一起，通过介绍和发布临床试验结果和其他TMH-CTN活动来传播TMH CTN的结果。相关性：我们认为，迄今为止，所有的试验都解决了所有需要网络参与才能成功的输血医学和止血的重要问题。这与原始RFA提案和RFA的既定目标都保持一致，以延续TMH-CTN。