Drawz Sarah M, Marschner Susanne, Yañez Martha, García de Coca Alfonso, Feys Hendrik B, Deeren Dries, Coene José
Department of Lab Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.
Terumo BCT, Lakewood, Colorado.
Transfusion. 2015 Jul;55(7):1745-51. doi: 10.1111/trf.13026. Epub 2015 Feb 23.
Mirasol pathogen reduction technology (PRT) treatment inactivates bacteria, viruses, and parasites in plasma products and platelets (PLTs) suspended in plasma and PLT additive solutions (PAS). Few clinical studies exist documenting transfusions with PAS. This study objective was to evaluate the count increments of PRT-treated PAS-C and PAS-E buffy coat (BC) PLTs in routine use observational settings.
PLT pools of five or six BCs were collected, processed, and suspended in PAS-C or PAS-E, respectively. Products were exposed to ultraviolet light in the presence of riboflavin and then transfused into 19 patients with hematologic diseases. Patients were monitored for PLT corrected count increment (CCI) at 1 and 24 hours and for any adverse events in the 72 hours after transfusion. Sterility monitoring was performed with a microbial detection system (BacT/ALERT, bioMérieux).
The PAS-E products had significantly higher PLT concentrations and counts than the PAS-C products. The mean CCIs of per-protocol (PP) units at 1 and 24 hours were 11,900 (n=27) and 5500 (n=30), respectively. Seventy-eight percent of PP transfusions classify as successful with CCIs at 1 hour of higher than 7500, and 63% higher than 4500 at 24 hours. One patient was excluded from all analyses as she was refractory to Mirasol-treated PLT transfusions and follow-up untreated transfusion products. No adverse events were observed and no contaminated products were detected by BacT/ALERT.
PRT-treated BC PLTs in PAS-C or PAS-E demonstrate PLT transfusion success rates in hematology patients with thrombocytopenia that are comparable to previous studies examining PLTs stored in plasma.
Mirasol病原体灭活技术(PRT)可使血浆制品以及悬浮于血浆和血小板添加剂溶液(PAS)中的血小板(PLT)中的细菌、病毒和寄生虫失活。关于使用PAS进行输血的临床研究较少。本研究的目的是在常规使用的观察环境中评估经PRT处理的PAS-C和PAS-E Buffy层(BC)血小板的计数增加情况。
收集五或六个BC的血小板池,分别进行处理并悬浮于PAS-C或PAS-E中。产品在核黄素存在的情况下暴露于紫外线下,然后输给19例血液系统疾病患者。在输血后1小时和24小时监测患者的血小板校正计数增加(CCI),并在输血后72小时内监测任何不良事件。使用微生物检测系统(BacT/ALERT,生物梅里埃公司)进行无菌监测。
PAS-E产品的血小板浓度和计数明显高于PAS-C产品。按方案(PP)单位在1小时和24小时的平均CCI分别为11,900(n = 27)和5500(n = 30)。78%的PP输血在1小时时CCI高于7500被分类为成功,63%在24小时时高于4500。一名患者被排除在所有分析之外,因为她对Mirasol处理的血小板输血和后续未处理的输血产品均无反应。未观察到不良事件,且BacT/ALERT未检测到受污染的产品。
在PAS-C或PAS-E中经PRT处理的BC血小板在血小板减少的血液学患者中显示出与先前研究中检查储存在血浆中的血小板相当的血小板输血成功率。