Transfusion/Hemostasis Clinical Research Network

描述（由申请人提供）： 这是宾夕法尼亚大学医学院教师参加计划中的输血医学/止血临床试验网络的申请。 该小组包括宾夕法尼亚大学卫生系统（UPHS）、费城儿童医院（CHOP）和美国红十字会宾夕法尼亚-泽西分部（PJ-ARC）的资源。 UPHS和CHOP正在进行大型合作项目，由Barbara A. Konkle，M. D、私家侦探和凯瑟琳·曼诺医学博士共同研究者，分别用于治疗遗传性和获得性止血疾病患者。 这些项目在参与临床试验方面有着长期的记录。此外，这些机构还为大型儿科和成人骨髓和干细胞移植项目、肝移植项目和创伤项目以及其他专业项目提供输血服务，包括提供细胞成分和血浆。 输血服务为血栓性血小板减少性紫癜等疾病提供血浆置换。 斯科特·墨菲医学博士作为该提案的共同研究者，他在血液学临床试验网络中的经验，是真性红细胞增多症研究小组的长期成员，也是国际公认的血小板输注专家。 墨菲博士，宾夕法尼亚大学的教员是PJ-ARC的医学主任。 提出了两项随机临床试验：1）来自富血小板血浆和血沉棕黄层的血小板浓缩物的比较，2）普通肝素与直接凝血酶抑制剂阿加曲班的抗凝作用以及心脏搭桥手术后血栓形成、血小板减少和不良临床结局的风险。 宾夕法尼亚大学可以为该网络提供广泛的资源，包括患者招募和临床试验设计和招募经验。 研究人员期待有机会积极参与这样一个网络，这将大大促进需要输血或患有遗传性或获得性止血障碍的儿童和成人的护理。

DESCRIPTION (provided by applicant): This is an application from University of Pennsylvania School of Medicine faculty to participate in the planned Transfusion Medicine/Hemostasis Clinical Trial Network. This group includes the resources of the University of Pennsylvania Health System (UPHS), the Children's Hospital of Philadelphia (CHOP) and the Penn-Jersey Division of the American Red Cross (PJ-ARC). UPHS and CHOP have ongoing large collaborative programs led by Barbara A. Konkle, M. D., the P.I. of this application, and Catherine Manno, M.D., a co-investigator, respectively, for the care of patients with inherited and acquired disorders of hemostasis. These programs have a long-standing record of participation in clinical trials. In addition, the institutions provide transfusion services, including the provision of cellular components and plasma, to large pediatric and adult bone marrow and stem cell transplantation programs, liver transplantation programs and trauma programs, among other specialized programs. The transfusion services provide plasmapheresis for disorders such as thrombotic thrombocytopenic purpura. Scott Murphy, M.D., a co-investigator in this proposal, lends his experience in clinical trial networks in hematology, having been a long standing member of the Polycythemia Vera study group and an internationally recognized expert in platelet transfusion. Dr. Murphy, a faculty member of the University of Pennsylvania is the Medical Director of the PJ-ARC. Two randomized clinical trials are proposed: 1) Comparision of Platelet Concentrates Derived from Platelet Rich Plasma and Buffy Coats and, 2) Anticoagulation with Unfractionated Heparin Versus the Direct Thrombin Inhbitor Argatroban and the Risk of Thrombosis, Thrombocytopenia and Adverse Clinical Outcomes Following Cardiopulmonary Bypass Surgery. The University of Pennsylvania can provide extensive resources for this Network including patients for enrollment and experience in clinical trial design and enrollment. The investigators look forward to the opportunity to actively participate in such a network which will significantly advance the care of children and adults requiring transfusion or suffering from inherited or acquired disorders of hemostasis.