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职员工申请参加计划中的输血医学/止血临床试验网络。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-泽西州分会(PJ-ARC)的资源。UPHS和CHOP有正在进行的大型合作项目，分别由该应用的P.I.医学博士芭芭拉·A·康克尔和医学博士凯瑟琳·曼诺领导，用于治疗遗传性和获得性止血障碍患者。这些项目参与临床试验的记录由来已久。此外，这些机构还提供输血服务，包括为大型儿科和成人骨髓和干细胞移植项目、肝脏移植项目和创伤项目提供细胞成分和血浆，以及其他专门项目。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·墨菲医学博士是这项建议的联合研究员，他借鉴了他在血液学临床试验网络方面的经验，他一直是维拉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。墨菲博士是宾夕法尼亚大学的一名教员，是PJ-ARC的医学主任。建议进行两项随机临床试验：1)比较从富血小板血浆和黄褐色涂层中提取的浓缩血小板；2)使用普通肝素和直接凝血酶抑制剂阿加曲班进行抗凝，并比较体外循环手术后血栓形成、血小板减少和不良临床结果的风险。宾夕法尼亚大学可以为这个网络提供广泛的资源，包括患者的登记和临床试验设计和登记的经验。调查人员期待有机会积极参与这一网络，这将大大促进对需要输血或患有遗传性或后天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.