Hemostasis Clinical Research Network Protocols

止血临床研究网络协议

• 批准号: 6931508
• 负责人: CINDY A LEISSINGER
• 金额: $ 30万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 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/6931508
• 关键词: blood disorder; chemoprevention; chemotherapy; clinical research; clinical trials; cooperative study; enzyme activity; experimental designs; hemophilia As; hemorrhage; hemostasis; human immunodeficiency virus; medical outreach /case finding; prothrombin; ribavirin; thrombocytopenic purpura

DESCRIPTION (provided by applicant): Patients with disorders of hemostasis are subject to long term problems and risks, difficult treatment decisions and risks associated with treatment itself. Many of these risks and complications can be lessened or prevented by appropriate intervention strategies. Advances in the management of patients with bleeding disorders of relatively low incidence require: 1) that clinical studies utilize a multi-institutional cooperative network in order to accrue sufficient numbers of patients to achieve meaningful answers; and 2) that patients be educated on the vital importance of participation in such studies. The purpose of this project is to develop a Hemostasis Core Clinical Research Unit at Tulane University as part of the NIH Transfusion Medicine/Hemostasis Clinical Research Network. This Unit will be developed using some of the basic infrastructure and services of the Tulane Center for Bleeding Disorders, which is dedicated to the care and advancement of patients with disorders of hemostasis. Once established, this Core Research Unit will provide access to clinical trials for hemostasis patients from the Center for Bleeding Disorders, the Bone Marrow Transplant Unit and from throughout the network of Tulane affiliated hospitals and clinics. In addition, two clinical trial protocols have been developed as part of this proposal. The first, A prospective randomized crossover study of activated prothrombin complex concentrates (aPCCs) as prophylactic therapy in hemophilia A patients with inhibitors, is a long-term protocol designed to evaluate the efficacy of aPCCs in the prevention of bleeds in this very complicated group of patients. The second, short-term protocol, A prospective study of ribavirin for the treatment of HIVassociated immunopathic thrombocytopenic purpura (ITP), was developed to test a novel pharmacologic agent in the management of HIV-ITP.

描述（由申请人提供）： 患有止血障碍的患者面临长期问题和风险、困难的治疗决策以及与治疗本身相关的风险。 许多这些风险和并发症可以通过适当的干预策略来减轻或预防。 发病率相对较低的出血性疾病患者的治疗进展需要：1）临床研究利用多机构合作网络，以积累足够数量的患者以获得有意义的答案； 2) 让患者了解参与此类研究的重要性。 该项目的目的是在杜兰大学建立止血核心临床研究单位，作为 NIH 输血医学/止血临床研究网络的一部分。 该科室将利用杜兰出血性疾病中心的一些基本基础设施和服务进行开发，该中心致力于治疗和促进止血疾病患者的治疗。一旦成立，该核心研究单位将为来自出血性疾病中心、骨髓移植单位以及整个杜兰大学附属医院和诊所网络的止血患者提供临床试验的机会。 此外，作为该提案的一部分，还制定了两项临床试验方案。 第一项是一项关于活化凝血酶原复合物浓缩物（aPCC）作为具有抑制剂的 A 型血友病患者的预防性治疗的前瞻性随机交叉研究，是一项长期方案，旨在评估 aPCC 在这一非常复杂的群体中预防出血的功效。患者。 第二个短期方案是利巴韦林治疗 HIV 相关免疫性血小板减少性紫癜 (ITP) 的前瞻性研究，旨在测试治疗 HIV-ITP 的新型药物。