TRANSFUSION MEDICINE/HEMOSTASIS TRIAL SITE AT PSBC

描述（由申请人提供）： 建议在普吉特湾血液中心 (PSBC) 设立一个输血医学/止血临床试验点。 PSBC 是一个区域性血液计划，向西雅图及周边县的患者分发所有血液和血液制品。 预计网络临床试验将在西雅图的 6 家医院中进行，总共拥有 2,193 个床位，2001 年期间，这些医院的 20,996 名患者接受了超过 150,000 份血液制品。 华盛顿大学医学院的四位在 PSBC 拥有丰富临床试验经验的教员将与其他试验中心一起参与网络临床试验。 这些医学科学家都是其研究兴趣领域公认的专家；即血小板和粒细胞输注治疗、单采术及其适应症、止血和血栓形成疾病以及 ITP 患者。 这些医生负责监督 PSBC 专门从事血友病护理的止血诊所、凝血实验室、血小板抗体实验室和单采设备。 通过这些临床活动，他们了解除了地区医院的患者之外，患有各种疾病的患者可能是参与网络临床试验的候选人。 提出两项网络临床试验：1）“评估低剂量与标准剂量血小板治疗的止血功效和血小板利用率；” 2) 关于将 G-CSF 动员的粒细胞输注给中性粒细胞减少感染患者的功效的多中心随机对照试验。第一项试验旨在确定与标准剂量血小板输注相比，低剂量是否能够维持足够的止血，同时减少支持血小板减少患者所需的血小板总数。主要终点将是止血；即证明随机患者的非劣效性低剂量组与标准近距离组相比，发生 WHO 2 级出血的患者百分比。 第二项试验将评估粒细胞输注疗法的有效性，以确定 G-CSF 动员粒细胞输注对细菌或真菌感染的中性粒细胞减少患者的临床疗效。 患者将被随机分配接受每日粒细胞输注以及标准护理或仅接受标准护理。 主要终点是每组中表现出对感染的微生物反应并且从研究开始至少存活 28 天的患者比例。

DESCRIPTION (provided by applicant): A Transfusion Medicine/Hemostasis Clinical Trial Site to be located at the Puget Sound Blood Center (PSBC) is proposed. PSBC is a regional blood program that distributes all blood and blood products to patients in Seattle and surrounding counties. It is anticipated that network clinical trials will be conducted at any of 6 Seattle hospitals that have a total of 2,193 beds, and, during 2001, 20,996 patients in these hospitals received over 150,000 blood products. Four University of Washington medical school faculty, based at PSBC, with extensive experience in clinical trials will participate with other trial sites in the network clinical trials. These physician scientists are all recognized experts in their areas of research interest; i.e., platelet and granulocyte transfusion therapy, apheresis procedures and their indications, disorders of hemostasis and thrombosis, and patients with ITP. These physicians supervise a hemostasis clinic at PSBC that specializes in hemophilia care, a coagulation laboratory, a platelet antibody laboratory, and an apheresis facility. Through these clinical activities, they are aware of patients with a variety of disorders - besides those in area hospitals - who might be candidates for participation in network clinical trials. Two network clinical trials are proposed: 1) "Evaluate The Hemostatic Efficacy And Platelet Utilization Rates Of Low Versus Standard Dose Platelet Therapy;" and 2) A Multicenter Randomized Controlled Trial On The Efficacy Of Transfusion Of G-CSF Mobilized Granulocytes To Neutropenic Patients With Infection." The first trial seeks to determine whether low dose compared to standard dose platelet transfusions are able to maintain adequate hemostasis while decreasing the total number of platelets required to support thrombocytopenic patients. The primary endpoint will be hemostasis; i.e., to demonstrate non-inferiority of patients randomized to the low dose arm compared to those in the standard close arm in the percentage of patients that develop WHO Grade 2 bleeding. The second trial will evaluate the effectiveness of granulocyte transfusion therapy to determine the clinical efficacy of G-CSF mobilized granulocyte transfusions for neutropenic patients with bacteria or fungal infections. Patients will be randomized to receive daily granulocyte transfusions along with standard care or standard care alone. The primary endpoint will be the proportion of patients in each arm who demonstrate both a microbial response to their infection and who also survive at least 28 days from study entry.