Transfusion Medicine/Hemostasis Clinical Research Netwo*

输血医学/止血临床研究网络*

• 批准号: 6571564
• 负责人: GILBERT C. WHITE, II
• 金额: $ 30万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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/6571564
• 关键词: biotherapeutic agent; blood /lymphatic pharmacology; blood bank /supply contamination; blood coagulation; blood disorder chemotherapy; blood transfusion; clinical research; clinical trial phase I; cooperative study; hemorrhage; hemostasis; hemostatics; human subject; human therapy evaluation; longitudinal human study; patient oriented research; plasma; platelet preservation; recombinant proteins; thrombocytopenic purpura; trauma

DESCRIPTION (provided by applicant): Clinical disorders that affect hemostasis and require replacement transfusions are common and life threatening disorders. Progress in developing better methods of defining new and more effective treatments for these disorders is complicated by the lack of mechanisms for coordinated studies. This application is in response to an RFA to participate in a Transfusion Medicine/Hemostasis Clinical Research Network. The resources available at the University of North Carolina at Chapel Hill for participation in a such a network are described, including the institutional commitment and excellence in the areas of hemostasis and transfusion medicine and the strong institutional emphasis on clinical research and the resources supporting clinical research. These resources provide well-defined study populations and access to large numbers of patients. Two clinical trials are proposed for the network. The first is a short term, multicenter study to use automated culture to monitor bacterial contamination of platelet concentrates under normal storage conditions. The aim of the study is to extend the shelf life of platelets. Platelet concentrates will be cultured on day 2 and the results of the culture used to extend the shelf life of sterile platelets from 5 to 7 days. The second study is a long term, multicenter, double-masked, placebo-controlled trial of recombinant VIla in patients with severe trauma and uncontrolled bleeding. The aim of the study is to determine the efficacy of recombinant factor Vlla as a hemostatic agent in severe trauma with bleeding that is refractory to standard replacement with fresh frozen plasma. The primary endpoint in the study is survival, determined at 24 h, 48 h, and 28 days. The secondary endpoints are the number of blood products infused, the number of days on ventilatory assistance, the number of days in the intensive care unit, the number of hospital days, and the extent of organ dysfunction.

描述（由申请人提供）： 影响止血并需要置换输血的临床疾病是常见的危及生命的疾病。 由于缺乏协调研究的机制，在开发更好的方法来确定新的和更有效的治疗这些疾病的进展是复杂的。 本申请是对RFA参与输血医学/止血临床研究网络的回应。 在查佩尔山的北卡罗来纳州的大学可用于参与这样一个网络的资源进行了描述，包括机构的承诺和卓越的止血和输血医学领域和强大的机构强调临床研究和支持临床研究的资源。 这些资源提供了明确的研究人群和大量患者。 为该网络提出了两项临床试验。 第一项是一项短期、多中心研究，使用自动培养来监测正常储存条件下血小板浓缩物的细菌污染。 该研究的目的是延长血小板的保质期。 将在第2天培养血小板浓缩物，并将培养结果用于将无菌血小板的有效期从5天延长至7天。 第二项研究是重组VIla在严重创伤和不受控制的出血患者中的长期、多中心、双盲、安慰剂对照试验。 该研究的目的是确定重组因子VIIa作为止血剂在严重创伤中的功效，所述严重创伤具有用新鲜冷冻血浆进行标准置换难治的出血。 研究的主要终点是生存期，分别在24小时、48小时和28天确定。 次要终点是输注血液制品的数量、接受辅助治疗的天数、在重症监护室的天数、住院天数和器官功能障碍的程度。