Transfusion Medicine/Hemostasis Core Clinical Center

输血医学/止血核心临床中心

• 批准号: 6569420
• 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
• 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/6569420
• 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

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)对拟议的输血医学/止血核心临床中心的描述、临床试验的研究人员经验、环境(DeGowin血液中心、综合临床研究中心、止血/血栓实验室)以及可用于参与拟议的临床试验的大量输血/止血疾病患者；2)一项题为《重组活化蛋白C和血浆置换治疗血栓性微血管病》的短期多中心临床试验，该试验比较了血栓性微血管病患者随机分配到标准(治疗性血浆置换)或试验性(治疗性血浆置换加活化蛋白C)治疗组的几项临床和实验室结果；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，该试验比较了随机分配到标准免疫抑制组(环磷酰胺、长春新碱、强的松)或试验组(相同的免疫抑制加Rituximab抗CD-20)的凝血因子VIII自身抗体患者的结果；以及4)包含关键个人的数据和承诺书的附录，以证明我们满足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、大量潜在的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。