TRANSFUSION TRIAL TO PREVENT PLATELET ALLOIMMUNIZATION

拟议的协调中心将与选定的 国家心脏、肺和血液研究所（NHLBI） 在随机临床试验的设计和性能，以确定 最好的临床有用的技术，以防止或减少 同种异体免疫是血小板输注无效的原因。 将一个或多个治疗组与对照组进行比较， 常规制备随机供体血小板浓缩物， 制备红细胞产品。协调中心将提供数据 管理、报告服务、数据分析和整体研究 协调和管理，协调中央职能 实验室由研究者决定。协调中心将 设计研究表格，编写方案和操作手册，以及 计划和实施随机化和研究质量控制程序。 每月质量控制报告将发送至临床中心， NHLBI。关于累积数据和临床中心的详细报告 将每六个月向数据和安全部门提供一次性能报告。 监查委员会（DSMB）。DSMB和DSMB要求的其他分析 还将提供NHLBI。协调中心的调查人员将 发挥执行秘书处的作用，并与其他 研究者分析研究数据以进行展示， 出版物

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.