Transfusion Medicine/Hemostasis Clinical Trials Network

输血医学/止血临床试验网络

• 批准号: 7278895
• 负责人: ELLIS J NEUFELD
• 金额: $ 22.83万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 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 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7278895
• 关键词: 6-Aminocaproic Acid; Area; Argatroban; B-Lymphocytes; Boston; Caring; Child; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Conduct Clinical Trials; Critiques; Data Coordinating Center; Development; Disease; Dose; Funding; Hematological Disease; Hematology; Hemophilia A; Hemorrhage; Hemostatic function; Heparin; Hospitals; Immune; Institutes; Medicine; Mission; Nature; New England; Non-Malignant; Numbers; Operative Surgical Procedures; Oral; Patients; Phase; Physicians; Platelet Transfusion; Prevention; Principal Investigator; Process; Protocols documentation; Publications; Randomized Controlled Clinical Trials; Range; Research; Resources; Sample Size; Scientist; Site; Standards of Weights and Measures; Structure; Teaching Hospitals; Thinking; Thrombocytopenia; Thrombocytopenic Purpura; Thrombopoietin; Training; Transfusion; United States National Institutes of Health; Work; fondaparinux; inhibitor/antagonist; mimetics; patient oriented research; prevent; programs; rituximab; success

DESCRIPTION (provided by applicant) This is a five year renewal application for the Transfusion Medicine/Hemostasis Clinical Research Network (TMHCRN). The mission of the TMH is to launch key clinical trials in the related fields of transfusion medicine, and in treatment of bleeding and bleeding disorders. The range of potential disorders spanned by the TMHCRN is wide, and reflected by the structure of the network into committees devoted to domains within these broad fields. The network is composed of 17 US core sites, a data coordinating center, and a number of consortium and project-specific collaboration partners. The multicenter nature of the network is critical for sample size considerations in studies of rare blood disorders. This application represents a consortium of three Harvard teaching hospitals, with demonstrated capability for network participation and active accrual to the current network studies. To date, the network has launched three active clinical studies, one on optimal platelet transfusion dose in thrombocytopenia, one on treatment of long INR to prevent surgical bleeding, and one on treatment of congenital hemophilia with inhibitors with the targeted anti-B cell agent, rituximab. This renewal application details several studies in the pipeline already, which will be launched during the upcoming five year period. In addition, specific new protocols are proposed, the result of network-wide "think tank" activities during 2006. The plan is to further develop and launch these studies in turn through the steering committee development and approval process, and through the pipeline in turn. (I) a phase III study of fondaparinux versus argatroban in the treatment of isolated heparin induced thrombocytopenia; (II) A randomized trial of epsilon- aminocaproic acid and platelet transfusions vs platelet transfusion alone in the prevention of bleeding in thrombocytopenic patients, and (III) a randomized trial of an oral thrombopoietin-mimetic agent plus standard care, versus standard care, in children with persistent immune thrombocytopenic purpura (ITP). The network serves as a fertile ground for collaborative research, and a particularly important resource for training young physician scientists in patient-oriented research in transfusion medicine and non-malignant hematology, in accordance with recent initiatives of NIH overall, and of NHLBI. CHILDREN'S HOSPITAL BOSTON CRITIQUES

描述（由申请人提供） 这是输血医学/止血临床研究网络 (TMHCRN) 的五年续展申请。 TMH 的使命是在输血医学相关领域以及出血和出血性疾病的治疗领域开展关键临床试验。 TMHCRN 涵盖的潜在疾病范围很广，并通过专门负责这些广泛领域内的领域的委员会的网络结构反映出来。该网络由 17 个美国核心站点、一个数据协调中心以及多个联盟和特定项目的合作伙伴组成。网络的多中心性质对于罕见血液疾病研究中的样本量考虑至关重要。该应用程序代表了由三个哈佛教学医院组成的联盟，具有网络参与能力和对当前网络研究的积极累积能力。迄今为止，该网络已启动三项活跃的临床研究，一项是关于血小板减少症的最佳血小板输注剂量，一项是关于治疗长INR以防止手术出血，一项是关于用靶向抗B细胞药物的抑制剂治疗先天性血友病。利妥昔单抗。该更新申请详细介绍了已经在进行中的几项研究，这些研究将在未来五年内启动。此外，还提出了具体的新协议，这是2006年全网络“智库”活动的结果。该计划是通过指导委员会的制定和批准程序，并通过管道依次进一步开发和启动这些研究。 (I) 磺达肝癸钠与阿加曲班治疗孤立性肝素诱导的血小板减少症的 III 期研究； (II) 一项关于ε-氨基己酸和血小板输注与单独输注血小板在预防血小板减少症患者出血方面的随机试验，以及 (III) 一项口服血小板生成素模拟药物加标准治疗与标准治疗的随机试验，患有持续性免疫性血小板减少性紫癜（ITP）的儿童。根据 NIH 整体和 NHLBI 的最新举措，该网络是合作研究的沃土，也是培训年轻医师科学家进行输血医学和非恶性血液学以患者为导向的研究的特别重要的资源。 波士顿儿童医院的批评