Abstract：
BACKGROUND: Current procedures for thawing and issuing of cryopreserved platelets (CPPs) are laborious and have remained challenging in emergency settings such as blood banks and military operations. In this prospective study, a novel processing method designed to facilitate the rapid issuance of CPPs with no postthaw handling required was developed and functionally characterized in parallel with standard CPPs manufactured.
METHODS: Double-dose plateletpheresis units (n = 42) were cryopreserved at -80°C in 5%-6% dimethyl sulfoxide to produce matched pairs thawed successively over a 27-month period for comparison between two processing arms. In contrast to the standard CPPs manufactured as standalone units, platelets were frozen in tandem with resuspending plasma in a distinct partition as a single unit in the novel method, herein referred to as tandem CPPs. Postthaw (PT) CPPs from both arms were assessed at PT0-, 12-, and 24-h to measure platelet recovery, R-time (time to clot initiation; min), and maximum amplitude (MA; clot strength; mm) using thromboelastography.
RESULTS: In the overall dataset, mean platelet recovery was higher (p < .0005) for tandem CPPs (83.9%) compared with standard CPPs (73.3%) at PT0; mean R-times were faster (p < .0005) for tandem CPPs (2.5-3.6 min) compared with standard CPPs (3.0-3.8 min); mean MA was higher for tandem CPPs (57.8-59.5 mm) compared with standard CPPs (52.1-55.8 mm) at each postthaw time point (p < .05).
CONCLUSIONS: Robust temporal dynamics of superior hemostatic functionality were established for tandem CPPs over extended cryopreservation up to 27 months and 24 h of postthaw storage.
METHODS: Double-dose plateletpheresis units (n = 42) were cryopreserved at -80°C in 5%-6% dimethyl sulfoxide to produce matched pairs thawed successively over a 27-month period for comparison between two processing arms. In contrast to the standard CPPs manufactured as standalone units, platelets were frozen in tandem with resuspending plasma in a distinct partition as a single unit in the novel method, herein referred to as tandem CPPs. Postthaw (PT) CPPs from both arms were assessed at PT0-, 12-, and 24-h to measure platelet recovery, R-time (time to clot initiation; min), and maximum amplitude (MA; clot strength; mm) using thromboelastography.
RESULTS: In the overall dataset, mean platelet recovery was higher (p < .0005) for tandem CPPs (83.9%) compared with standard CPPs (73.3%) at PT0; mean R-times were faster (p < .0005) for tandem CPPs (2.5-3.6 min) compared with standard CPPs (3.0-3.8 min); mean MA was higher for tandem CPPs (57.8-59.5 mm) compared with standard CPPs (52.1-55.8 mm) at each postthaw time point (p < .05).
CONCLUSIONS: Robust temporal dynamics of superior hemostatic functionality were established for tandem CPPs over extended cryopreservation up to 27 months and 24 h of postthaw storage.
摘要：
背景：目前用于解冻和发放冷冻保存的血小板（CPPs）的程序是费力的，并且在诸如血库和军事行动等紧急情况下仍然具有挑战性。在这项前瞻性研究中，开发了一种新颖的处理方法，该方法旨在促进CPPs的快速发行，而无需解冻后处理，并在功能上与制造的标准CPPs并行进行表征。
方法：将双剂量血小板分离单位（n=42）在-80°C下冷冻保存在5％-6％的二甲基亚砜中，以产生在27个月内连续解冻的匹配对。两个处理组之间的比较。与作为独立单元制造的标准CPP相比，在新方法中，将血小板与重悬血浆串联冷冻在不同的分区中，作为单个单元，本文称为串联CPP。在PT0-时评估来自两组的解冻后(PT)CPP，12-，和24小时测量血小板恢复，R-时间（凝块起始时间；分钟），和使用血栓弹力图的最大振幅（MA；凝块强度；mm）。
结果：在整个数据集中，与标准CPPs(73.3%)相比,在PT0时,串联CPPs(83.9%)的平均血小板回收率更高(p<.0005);与标准CPPs(3.0-3.8min)相比,串联CPPs(2.5-3.6min)的平均R时间更快(p<.0005);与标准CPPs(52.1-55.8mm)相比,串联CPPs的平均MA值更高(57.8-5
结论：在解冻后储存27个月和24小时的延长冷冻保存过程中，串联CPPs具有良好的止血功能。
方法：将双剂量血小板分离单位（n=42）在-80°C下冷冻保存在5％-6％的二甲基亚砜中，以产生在27个月内连续解冻的匹配对。两个处理组之间的比较。与作为独立单元制造的标准CPP相比，在新方法中，将血小板与重悬血浆串联冷冻在不同的分区中，作为单个单元，本文称为串联CPP。在PT0-时评估来自两组的解冻后(PT)CPP，12-，和24小时测量血小板恢复，R-时间（凝块起始时间；分钟），和使用血栓弹力图的最大振幅（MA；凝块强度；mm）。
结果：在整个数据集中，与标准CPPs(73.3%)相比,在PT0时,串联CPPs(83.9%)的平均血小板回收率更高(p<.0005);与标准CPPs(3.0-3.8min)相比,串联CPPs(2.5-3.6min)的平均R时间更快(p<.0005);与标准CPPs(52.1-55.8mm)相比,串联CPPs的平均MA值更高(57.8-5
结论：在解冻后储存27个月和24小时的延长冷冻保存过程中，串联CPPs具有良好的止血功能。
