TRANSFUSION TRIAL TO PREVENT PLATELET ALLOIMMUNIZATION

本建议书是根据RFA NIH88-HL-12B的要求提交的 一项旨在确定实用方法的研究中的临床中心 减少异体免疫和顽固性的发生率 急性心肌梗死多次输注患者的血小板输注 非淋巴细胞白血病(ANLL)。输血疗法在以下方面 考虑使用：随机、单一的血小板浓缩物 通过分离技术制备的供体；缺乏白细胞的血小板 浓缩物；和暴露在紫外线下的浓缩血小板 辐射。受试者中异基因免疫的发生率 将确定各种协议，并将其与 “对照组”用标准配制的浓缩血小板。 这项研究将是前瞻性的、随机的、单盲的。病人 将根据人口统计学被分配到特定的研究部队 协调中心提供的信息，包括孕产史等 中心。新诊断为ANLL的患者接受诱导 在密尔沃基和密尔沃基大学选定的医院接受治疗 麦迪逊的威斯康星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 适应症和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-獾地区。 对血小板输注的异体免疫和耐受性将是 由临床和实验室参数决定。的决定 难治性与免疫性或非免疫性有关 因素(如败血症、发烧等)可以通过对以下内容的答复来澄清 人类白细胞抗原配型匹配的血小板输注。两个地区血液中心都保持着 一份广泛的HLA型捐赠者名单，应该能够获得 及时输注足够量的人类白细胞抗原相合的血小板。 同种异体免疫的实验室评估将通过化验确定 对于补体固定抗体和非补体固定抗体反应 血小板上表达的人类白细胞抗原I类决定簇和其他同种异体抗原。 血小板上表达的非人类白细胞抗原同种异体抗原是一项重要的研究 威斯康星州东南部血液中心的利益。《血色》 中心将愿意提供同种抗体的参考检测 如有要求，可与这些决定因素反应。异体免疫是一种 临床医生治疗急性非淋巴白血病的棘手问题。建议数 研究应解决目前存在的关于 预防或减少其发生的方法。

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.