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：
7122531
负责人：
RONALD G STRAUSS
金额：
$ 29.3万
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/7122531
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）： 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输血/止血疾病可参与拟议的临床试验； 2）一项一项短期多中心临床试验，标题为“在治疗凝血能微型疾病中的重组激活的蛋白C和血浆交换”，该试验比较了将血栓形成微型病随机分配给标准（司法性血浆交换）的几种临床和实验室结果，该临床和实验室结局是临床和实验室的（治疗型血浆交换）或实验性型plys plasse plassmam plassmam plassmam proscamma激活了激活; 3）一项一项长期多中心临床试验，标题为“利妥昔单抗和免疫抑制药物，用于治疗获得的自身抗体针对VIII因子VIII”，该试验比较了获得自身抗体的患者与凝结因子VIII随机分配为随机分配给标准免疫抑制作用的患者的结果免疫抑制和利妥昔单抗抗CD 20）治疗臂； 4）附录，其中包含关键个人的数据和承诺信，以记录我们满足RFA-HL-02-001的所有要求的能力。由于研究人员的专业知识，环境的卓越性，大量的潜在研究对象以及拟议的临床试验的实验/统计设计质量，爱荷华大学核心核心临床中心很可能会积极参与，并为NHLBI Thlbi Threfusion Threfusion Medicine/ HemoStasis临床研究网络做出有意义的贡献。