Transfusion Medicine/Hemostasis Clinical Research Netwo*

描述(由申请人提供)： 影响止血和需要补充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这些疾病的新的和更有效的治疗方法方面的进展是复杂的。这项申请是对参加输血医学/止血临床研究网络的RFA的响应。描述了北卡罗来纳大学教堂山分校可用于参与这样一个网络的资源，包括在止血和输血医学领域的机构承诺和卓越，以及机构对临床研究的强烈重视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接触大量患者的途径。为该网络提出了两项临床试验。第一项是一项短期的多中心研究，目的是使用自动化培养来监测正常储存条件下浓缩血小板的细菌污染。这项研究的目的是延长血小板的保质期。浓缩的血小板将在第2天进行培养，培养结果用于将无菌血小板的保质期从5天延长到7天。第二项研究是一项长期、多中心、双掩蔽、安慰剂对照的重组VILA试验，用于严重创伤和失血无法控制的患者。本研究的目的是确定重组因子V11a作为严重创伤合并出血的止血剂的疗效，这些出血是新鲜冰冻血浆无法标准替代的。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。次要终点是输血产品的数量、呼吸机辅助的天数、在重症监护病房的天数、住院天数和器官功能障碍的程度。

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.