Abstract：
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.
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.
摘要：
背景：血小板输注后可发生人类白细胞抗原（HLA）同种免疫。这些抗体可使将来的血小板输注或器官移植复杂化。动物数据表明，Mirasol病原体减少治疗（PRT）可以预防输血后的同种免疫。
方法：MIPLATE试验纳入了计划中的660名血液系统恶性肿瘤患者中的330名，有2级或更大出血风险。经过计划的中期分析后，该研究因徒劳而提前中止。与标准对照血小板相比，参与者被随机分配接受PRT。在基线（输血前）时收集参与者的血清样本，前4周每周一次,然后在第42天和第56天.使用商业的基于多分析物珠的测定法测定HLA抗体水平。HLA抗体水平分析使用低，中等,和基于先前研究的高截止值。
结果：在研究的两个方面，同种免疫率都很低，特别是在高HLA抗体截止值(总共277名受试者中有6名处于危险中，或2.2%）。同种免疫的风险在研究组之间没有差异，血小板输注的免疫难治性风险也没有。
结论：数据不支持MIPLATE试验中Mirasol对血小板输注后的同种免疫具有保护作用的结论。
方法：MIPLATE试验纳入了计划中的660名血液系统恶性肿瘤患者中的330名，有2级或更大出血风险。
结果：在研究的两个方面，同种免疫率都很低，
结论：数据不支持MIPLATE试验中Mirasol对血小板输注后的同种免疫具有保护作用的结论。
