TRANSFUSION TRIAL TO PREVENT PLATELET ALLOIMMUNIZATION

预防血小板同种免疫的输血试验

• 批准号: 3553376
• 负责人: Jay E Menitove
• 金额: $ 25.56万
• 依托单位: VERSITI WISCONSIN, INC.
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-08-01 至 1994-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3553376
• 关键词: acute leukemia; antileukocyte isoantibody; blood banks; blood donor; cell mediated lymphocytolysis test; clinical trials; complement fixation tests; enzyme linked immunosorbent assay; histocompatibility; histocompatibility antigens; human subject; immunosuppression; leukocyte antigen typing; leukocyte depletion therapy; platelet disorder; platelet transfusion; plateletpheresis

This proposal is submitted in response to RFA NIH 88-HL-12B to serve as a Clinical Center in a study designed to determine practical methods for reducing the incidence of alloimmunization and refractoriness to platelet transfusions in multitransfused patients with acute nonlymphocytic leukemia (ANLL). Transfusion therapies under consideration include use of: platelet concentrates from random, single donors prepared by apheresis techniques; leukocyte-poor platelet concentrates; and platelet concentrate exposed to ultraviolet irradiation. The incidence of alloimmunization in patients assigned to various protocols will be determined and will be compared with that of a "control" group treated with standardly prepared platelet concentrate. The study will be prospective, randomized, and single-blinded. Patients will be assigned to specific study arms on the basis of demographic information including history of pregnancy, etc. by the Coordinating Center. Patients with a new diagnosis of ANLL who undergo induction therapy at selected hospitals in Milwaukee and at the University of Wisconsin Hospitals in Madison will be eligible for the study. Platelet transfusions will be prescribed for therapeutic or prophylactic indications and will be prepared by The Blood Center of Southeastern Wisconsin and the American REd Cross Blood Services-Badger Region. Alloimmunization and refractoriness to platelet transfusions will be determined by clinical and laboratory parameters. Determination of whether refractoriness is related to immunologic or non-immunologic factors (e.g., sepsis, fever, etc.) may be clarified by the response to HLA-matched platelet transfusions. Both regional blood centers maintain an extensive list of HLA-typed donors and should be able to obtain an adequate number o HLA-matched platelet transfusions on a timely basis. Laboratory assessment of alloimmunization will be determined by assays for complement-fixing and non-complement-fixing antibodies reactive with class I HLA determinants and other alloantigens expressed on platelets. Non-HLA alloantigens expressed on platelets are a major research interest of The Blood Center of Southeastern Wisconsin. The Blood Center would be willing to provide reference testing for allo-antibodies reactive with such determinants if requested. Alloimmunization is a vexing problem for clinicians treating patients with ANLL. The proposed study should resolve existing questions about the effectiveness of methods for preventing or reducing its occurrence.

本提案是响应 RFA NIH 88-HL-12B 提交的，作为 临床中心进行一项旨在确定实用方法的研究 降低同种免疫和难治性的发生率 急性多次输血患者的血小板输注 非淋巴细胞白血病（ANLL）。 输血疗法 考虑因素包括使用： 随机、单一的血小板浓缩物 通过单采技术制备的供体；贫白细胞血小板 集中；和浓缩血小板暴露于紫外线 辐照。 分配给患者的同种免疫发生率 将确定各种协议并将其与 “对照组”用标准制备的血小板浓缩物治疗。 该研究将是前瞻性、随机和单盲的。 患者 将根据人口统计分配到特定的研究组 协调中心提供的信息，包括怀孕史等 中心。 新诊断 ANLL 并接受诱导的患者 在密尔沃基的选定医院和密尔沃基大学进行治疗 麦迪逊威斯康星州医院将有资格参加这项研究。 血小板 输血将用于治疗或预防 适应症并将由东南部血液中心准备 威斯康星州和美国红十字会血液服务中心獾地区。 同种免疫和血小板输注无效将 由临床和实验室参数确定。 测定 难治性是否与免疫或非免疫相关 因素（例如脓毒症、发烧等）可以通过对以下问题的反应来澄清： HLA 匹配的血小板输注。 两个区域血液中心均维持 一份广泛的 HLA 型捐献者名单，并且应该能够获得一份 及时输注足够数量的HLA匹配血小板。 同种免疫的实验室评估将通过测定来确定 用于与补体固定和非补体固定抗体发生反应的抗体 I 类 HLA 决定簇和血小板上表达的其他同种抗原。 血小板上表达的非 HLA 同种抗原是一项重大研究 威斯康星州东南部血液中心的兴趣。 血 中心愿意提供同种抗体参考检测 如果需要的话，可以对这些决定因素做出反应。 同种免疫是一种 对于治疗 ANLL 患者的临床医生来说，这是一个令人烦恼的问题。 拟议的 研究应解决有关有效性的现有问题 预防或减少其发生的方法。