Kaidarova Zhanna, Di Germanio Clara, Custer Brian, Norris Philip J
Vitalant Research Institute, San Francisco, California, USA.
Department of Laboratory Medicine, University of California, San Francisco, California, USA.
Transfusion. 2023 Apr;63(4):791-797. doi: 10.1111/trf.17286. Epub 2023 Feb 25.
Human leukocyte antigen (HLA) alloimmunization can occur after platelet transfusion. These antibodies can complicate future platelet transfusions or organ transplantation. Animal data suggest that Mirasol pathogen reduction treatment (PRT) can prevent alloimmunization after transfusion.
The MIPLATE trial enrolled 330 of a planned 660 participants with hematological malignancies at risk for grade 2 or greater bleeding. The study was halted early for futility after a planned interim analysis. Participants were randomized to receive PRT versus standard control platelets. Serum samples were collected from participants at baseline (pretransfusion), weekly for the first 4 weeks, then at days 42 and 56. HLA antibody levels were determined using a commercial multianalyte bead-based assay. HLA antibody levels were analyzed using low, medium, and high cutoffs based on prior studies.
The rate of alloimmunization was low in both arms of the study, particularly at the high HLA antibody cutoff (total of 6 of 277 subjects at risk, or 2.2%). The risk of alloimmunization did not differ between study arms, nor did the risk of immune refractoriness to platelet transfusion.
The data do not support the conclusion that Mirasol exerted a protective effect against alloimmunization after platelet transfusion in the MIPLATE trial.
血小板输注后可发生人类白细胞抗原（HLA）同种免疫。这些抗体可使未来的血小板输注或器官移植变得复杂。动物数据表明，Mirasol病原体灭活处理（PRT）可预防输血后的同种免疫。
MIPLATE试验纳入了计划招募的660名有2级或更高级别出血风险的血液系统恶性肿瘤患者中的330名。在计划的中期分析后，该研究因无效而提前终止。参与者被随机分配接受PRT处理的血小板与标准对照血小板。在基线（输血前）、前4周每周、然后在第42天和第56天从参与者收集血清样本。使用基于商业多分析物微珠的检测方法测定HLA抗体水平。根据先前的研究，使用低、中和高临界值分析HLA抗体水平。
研究的两个组中同种免疫的发生率都很低，特别是在高HLA抗体临界值时（277名有风险的受试者中共有6名，即2.2%）。研究组之间同种免疫的风险没有差异，对血小板输注产生免疫不应性的风险也没有差异。
在MIPLATE试验中，数据不支持Mirasol对血小板输注后同种免疫有保护作用这一结论。
