TMH Clinical Trials Network-Wisconsin Core Clinical Center

描述(由申请人提供) 项目概述：当输血医学和止血(TMH)临床试验网络(CTN)于2002年启动时，威斯康星州血液中心(BCW)与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。在资助的最初5年里，威斯康星州TMH研究人员一直积极参与该网络的活动，帮助在该网络涉及的几个关键领域进行试验，并将患者纳入首个获得批准的网络研究--“确定预防血小板减少症患者出血的最佳预防性血小板剂量策略”或PLADO。这项提议是在未来5年内继续我们的CCC参与TMH-CTN，帮助在这些医学领域建立和实施更多的临床试验。具体地说，我们建议：1)继续参与到目前为止已经启动的TMH-CTN试验(PLADO，“止血和侵入性程序研究”(SHIP)和“利妥昔单抗治疗先天性血友病A中的抑制剂”(RICH))，并在这些试验获得批准后增加新的试验(例如：“管道”试验：“HIT观察性血栓栓塞症研究”(HOT)、“TTP和利妥昔单抗研究：随机临床试验”(STAR)和“大剂量粒细胞输注治疗中性粒细胞减少症感染”(粒细胞试验)，以及其他正在开发和批准的试验。2)积极参与网络指导委员会和小组委员会的活动，提议、制定和向网络批准止血和输血医学领域的其他相关研究3)发展合作关系和支持培训机会，以促进拟议的临床试验的成功，并促进输血医学和止血领域的进一步发展。4)与TMH的同事一起，通过介绍和发布临床试验结果和TMH-CTN的其他活动来传播TMH CTN的结果。相关性：我们认为，到目前为止开展的所有试验都解决了输血医学和止血方面的重要问题，需要网络参与才能取得成功。这既符合区域金融机构最初的提议，也符合区域金融机构关于继续保留TMH-CTN的既定目标。

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.