TRANSFUSION MEDICINE/HEMOSTASIS TRIAL SITE AT PSBC

邮储银行输血/止血试验现场

• 批准号: 6783278
• 负责人: Sherrill J. Slichter
• 金额: $ 30万
• 依托单位: BLOODWORKS
• 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/6783278
• 关键词: bacterial disease; bactericidal immunity; blood transfusion; clinical research; clinical trials; cooperative study; dosage; hemorrhage; hemostasis; human subject; human therapy evaluation; immunity; leukocyte transfusion; mycosis; neutropenia; patient oriented research; platelet transfusion; thrombocytopenia

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.

描述（由申请人提供）： 拟在普吉特湾血液中心（PSBC）设立输血医学/止血临床试验中心。 PSBC是一个区域性的血液计划，向西雅图和周边县的患者分发所有血液和血液制品。 预计将在总共有2，193张病床的6家西雅图医院中的任何一家进行网络临床试验，2001年期间，这些医院的20，996名病人接受了150，000多份血液制品。 华盛顿大学医学院的四名教师将与其他试验中心一起参加网络临床试验。 这些医生科学家都是其研究领域的公认专家;即，血小板和粒细胞输注治疗、单采术程序及其适应症、止血和血栓形成障碍以及ITP患者。 这些医生监督PSBC的一个专门从事血友病护理的止血诊所、一个凝血实验室、一个血小板抗体实验室和一个单采设备。 通过这些临床活动，他们意识到除了地区医院的患者外，还有各种疾病的患者可能是参加网络临床试验的候选人。 提出了两项网络临床试验：1）“评价低剂量与标准剂量血小板治疗的止血疗效和血小板利用率”; 2）一项关于中性粒细胞减少感染患者输注G-CSF动员粒细胞疗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，低剂量血小板输注是否能够保持足够的止血，同时减少支持血小板减少症患者所需的血小板总数。 主要终点将是止血;即，证明随机分配至低剂量组的患者在发生WHO 2级出血的患者百分比方面非劣效于标准闭合组。 第二项试验将评估粒细胞输注治疗的有效性，以确定G-CSF动员的粒细胞输注对伴有细菌或真菌感染的血小板减少症患者的临床疗效。 患者将随机接受每日粒细胞输注沿着标准治疗或仅接受标准治疗。 主要终点将是每组中表现出对感染的微生物应答并且从研究入组起存活至少28天的患者比例。