Clinical Trials in Transfusion Medicine and Hemostasis

描述(由申请人提供) 医疗保健的不断发展、高科技疗法的采用以及血库技术的进步导致了输血疗法的创新。关于使用新的血液产品和止血疾病管理的明智决定产生了对国家临床试验网络的需求，以评估新的治疗方法。输血医学和止血(TMH)临床试验网络(CTN)成立于2002年。17个资助地点的主要研究人员和他们的合作者成功地开发和实施了输血医学和止血方面的临床试验。目前有效的方案包括血小板剂量(PLADO)、使用新鲜冰冻血浆(SHIP)，以及即将启动的方案：粒细胞输注、肝素引起的血小板减少症血栓形成的观察研究以及血友病抑制剂的利妥昔单抗。其他几个国家则不太发达。明尼苏达大学在成功的输血医学和止血临床试验方面有着悠久的历史。重点临床服务与止血、输血专业人员之间存在良好的生产关系。成功生产新型血液产品或为止血条件提供新疗法的资源可通过我们的分子和细胞设施和细胞治疗实验室、医院血库以及与传统血液供应商的良好关系获得。因此，我们建议继续参与输血医学和止血临床试验网络，以继续解决需要在多中心网络中进行科学研究的重要临床问题。在接下来的5年里，作为TMH CTN的一部分，我们建议参与该网络：维持并进一步加强一个结构，以支持输血医学和止血领域临床试验的开发、实施和进行。利用工作和研究监督小组委员会的结构来完成正在进行的试验，并开发、完善和完成本申请中提议的新试验。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，并进一步促进输血医学和止血领域的成功。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。

DESCRIPTION (provided by applicant) The continuing evolution in medical care, adoption of high technology therapies, and advances in blood banking technology have led to innovations in transfusion therapy. Wise decisions about the use of novel blood products and the management of hemostatic disorders has created a need for a national clinical trials network to evaluate new therapies. A Transfusion Medicine and Hemostasis (TMH) Clinical Trials Network (CTN) was established in 2002. The principal investigators and their collaborators at the 17 funded sites, have worked successfully to develop and implement clinical trials in transfusion medicine and hemostasis. Protocols presently active include platelet dose (PLADO), use of fresh frozen plasma (SHIP), and those soon to be initiated are: granulocyte transfusion, an observational study of thrombosis in heparin induced thrombocytopenia, and rituximab for inhibitors in hemophilia. Several others are less developed. The University of Minnesota has a long history of successful transfusion medicine and hemostasis clinical trials. There is an excellent productive relationship between key clinical services and hemostasis and transfusion medicine faculty. The resources to successfully produce novel blood products or to provide new therapies for hemostatic conditions are available through our Molecular and Cellular Facility and Cell Therapy Laboratory the hospital blood bank and through excellent relationships with traditional blood suppliers. Therefore we propose to continue to participate in the Transfusion Medicine and Hemostasis Clinical Trials Network to continue to address important clinical issues that need scientific study in a multi-center network. Over the next the 5 years, as part of the TMH CTN we propose to participate in the network to: Maintain, and further enhance, a structure to support the development, implementation and conduct of clinical trials in the areas of transfusion medicine and hemostasis. Utilize the structure of working and study oversight subcommittees to complete ongoing trials and develop, refine and complete new trials proposed in this application. 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. Disseminate results of the TMH CTN through presentation and publication of clinical trial results and other TMH CTN activities.