TRANSFUSION TRIAL TO PREVENT PLATELET ALLOIMMUNIZATION

预防血小板同种免疫的输血试验

• 批准号: 3553377
• 负责人: JANICE G MC FARLAND
• 金额: $ 29.94万
• 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/3553377
• 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.

该建议是根据RFA NIH 88-HL-12B提交的 一项旨在确定实用方法的研究中的临床中心 将同种异体免疫和磨性的发生率降低到 急性多转递送患者的血小板输血 非淋巴细胞白血病（ANLL）。 输血疗法下 考虑因素包括使用：随机，单一的血小板浓缩物 通过放置技术准备的供体；白细胞贫乏的血小板 浓缩物；和暴露于紫外线的血小板浓缩物 辐照。 分配给的患者的同种异体免疫的发生率 将确定各种协议，并将 用标准准备的血小板浓缩物处理的“控制”组。 该研究将是前瞻性，随机和单盲。 患者 将根据人群分配给特定的研究臂 通过协调的信息，包括怀孕病史等 中心。 对接受诱导的ANLL的新诊断患者 在密尔沃基和大学的选定医院进行治疗 麦迪逊的威斯康星州医院将有资格进行这项研究。 血小板 输血将用于治疗或预防性 适应症，将由东南血液中心准备 威斯康星州和美国红十字会血液服务 - 巴格地区。 对血小板输血的同种异体免疫和折射率将是 由临床和实验室参数确定。 确定 折射率是否与免疫学或非免疫学有关 可以通过对响应来阐明因素（例如，败血症，发烧等） HLA匹配的血小板输血。 两个区域血液中心保持 HLA类型的捐助者的广泛清单，应该能够获得 及时及时的足够数字O HLA匹配的血小板输血。 实验室评估同种异体免疫将由测定确定 用于补体固定和不配合固定抗体，用 在血小板上表达的I类决定因素和其他同种抗原。 在血小板上表达的非HLA同种抗原是一项主要研究 威斯康星州东南部的血液中心的兴趣。 鲜血 中心愿意为异抗体提供参考测试 如果要求，请用此类决定因素进行反应。 同种免疫是 治疗ANLL患者的临床医生的烦恼问题。 提议 研究应解决现有问题有关的问题 预防或减少其发生的方法。