Transfusion Medicine/Hemostasis Core Clinical Center

输血医学/止血核心临床中心

基本信息

批准号：
6662632
负责人：
RONALD G STRAUSS
金额：
$ 30万
依托单位：
UNIVERSITY OF IOWA
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-30 至 2007-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6662632
关键词：
artificial immunosuppression autoantibody blood disorder chemotherapy blood transfusion clinical research clinical trials coagulation factor VII cooperative study hemostasis human subject human therapy evaluation immunosuppressive monoclonal antibody patient oriented research protein C thrombocytopenic purpura thrombosis

项目摘要

DESCRIPTION (provided by applicant): This application responds to RFA-HL-02-001 entitled "Transfusion Medicine/Hemostasis Clinical Research Network" and consists of four major sections: 1) descriptions of the proposed Transfusion Medicine/Hemostasis Core Clinical Center, investigator experience with clinical trials, the environment (DeGowin Blood Center, General Clinical Research Center, Hemostasis/Thrombosis Laboratory), and the plethora of patients with transfusion/hemostatic disorders available to participate in proposed clinical trials; 2) one short-term multicenter clinical trial entitled "Recombinant Activated Protein C and Plasma Exchange in the Treatment of Thrombotic Microangiopathies" which compares several clinical and laboratory outcomes of patients with thrombotic microangiopathies randomly assigned to either standard (therapeutic plasma exchange) or experimental (therapeutic plasma exchange plus activated protein C) therapy arms; 3) one long-term multicenter clinical trial entitled "Rituximab and Immunosuppressive Drugs in the Treatment of Acquired Autoantibodies Against Factor VIII" which compares outcomes of patients with acquired autoantibodies against clotting factor VIII randomly assigned to either standard immunosuppression (cyclophosphamide, vincristine, prednisone) or experimental (identical immunosuppression plus Rituximab anti-CD 20) therapy arms; and 4) an appendix containing data and letters of commitment from key individuals to document our abilities to fulfill all requirements of RFA-HL-02-001. Because of the expertise of the investigators, the excellence of the environment, the large number of potential study subjects and the quality of the experimental/ statistical design of the proposed clinical trials, it is likely that The University of Iowa Core Clinical Center will actively participate and make meaningful contributions to the NHLBI Transfusion Medicine/Hemostasis Clinical Research Network.

描述（由申请人提供）：本申请响应题为“输血医学/止血临床研究网络”的 RFA-HL-02-001，由四个主要部分组成：1) 拟议输血医学/止血核心临床中心的描述、临床试验的研究者经验、环境（DeGowin 血液中心、普通临床研究中心、止血/血栓形成实验室），以及大量患有输血/止血疾病的患者可以参加拟议的临床试验； 2) 一项题为“重组激活蛋白 C 和血浆交换治疗血栓性微血管病”的短期多中心临床试验，该试验比较了随机分配至标准组（治疗性血浆置换）或实验组的血栓性微血管病患者的几种临床和实验室结果。治疗性血浆置换加活化蛋白 C) 治疗组； 3) 一项题为“利妥昔单抗和免疫抑制药物治疗获得性抗凝血因子 VIII 自身抗体”的长期多中心临床试验，该试验比较了具有抗凝血因子 VIII 获得性自身抗体的患者的结果，随机分配至标准免疫抑制（环磷酰胺、长春新碱、泼尼松）或实验性（相同的免疫抑制加利妥昔单抗抗 CD 20）治疗组； 4) 包含关键人员数据和承诺书的附录，用于记录我们满足 RFA-HL-02-001 所有要求的能力。由于研究人员的专业知识、卓越的环境、大量的潜在研究对象以及拟议临床试验的实验/统计设计的质量，爱荷华大学核心临床中心很可能会积极参与并为 NHLBI 输血医学/止血临床研究网络做出有意义的贡献。