TRANSFUSION TRIAL TO PREVENT PLATELET ALLOIMMUNIZATION

建议的协调中心将与选定的 临床中心和国家心肺血液研究所(NHLBI) 在设计和执行一项随机临床试验以确定 预防或最小化的最佳临床有用技术 同种异体免疫是血小板输注无效的原因。 一个或多个治疗臂将与控制臂进行比较 常规制备随机供体血小板浓缩物 准备了红血球产品。协调中心将提供数据 管理、报告服务、数据分析和整体研究 协调管理，协调中央职能 由调查人员决定的实验室。协调中心将 设计学习表格，编写操作规程和手册，以及 计划和实施随机化，研究质量控制程序。 每月的质量控制报告将发送到临床中心和 NHLBI。关于积累数据和临床中心的详细报告 每六个月向数据和安全部门提供一次绩效报告 监控板(DSMB)。Dsmb要求的其他分析和 还将提供NHLBI。协调中心的调查人员将 担任执行秘书处，并与其他 研究人员在分析研究数据以进行演示和 出版。

The proposed Coordinating Center will participate with the selected Clinical Centers and the National Heart, Lung and Blood Institute (NHLBI) in the design and performance of a randomized clinical trail to determine the best clinically useful techniques to prevent or minimize alloimmunization as a cause of refractoriness to platelet transfusion. One or more treatment arms will be compared with a control arm of routinely prepared random-donor platelet concentrates and routinely prepared red cell products. The coordinating Center will provide data management, reporting services, data analysis, and overall study coordination and management, and coordinate the function of the Central Laboratory as decided by the investigators. The Coordinating Center will design the study forms, write the protocol and manual of operations, and plan and implement randomization and study quality control procedures. Monthly quality control reports will be sent to the Clinical Centers and the NHLBI. Detailed reports on the accumulating data and Clinical Center performance will be provided every six months to the Data and Safety Monitoring Board (DSMB). Other analyses as required by the DSMB and the NHLBI will also be provided. The Coordinating Center investigators will function as executive secretariat and collaborate with other investigators in analyzing the study data for presentation and publication.