复杂心胸外科手术中低温和室温下储存血小板对比的初步试验
背景：与标准室温储存血小板（20°~24°C）相比，本次试验着重于提供初步数据评估复杂心胸外科手术中成年患者输注低温储存血小板（2°~6°C）止血潜力的可行性和安全性，以期为将来的进一步的重要试验提供数据。
方法：本研究是一项单中心两阶段的初步研究，纳入了行择期或半紧急的复杂心胸外科手术的成年患者。第一阶段是一项双臂随机试验，对在低温储存7天内的血小板与在室温储存血小板输注的止血潜力进行比较。在随后的II期阶段的单臂试验中，使用低温储存8-14天的血小板。主要监测指标是通过胸腔引流量判定临床效果。次要监测指标是通过多电极阻抗凝集法测量血小板功能、收集全血用量、即时和长期（28天）不良事件、重症监护室住院时间以及死亡率。
结果：在第一阶段试验中，输注室温储存血小板患者的胸水引流量中位数为720mL（四分位数485-1170，n=25），而输注存储血小板患者的胸水引流量中位数为645mL（四分位数460-800，n=25），两者之间没有显著差异。双臂随机试验中，输注室温和低温储存7天内血小板之间的胸水排出引流量中位数差异为75mL（95％CI，-220，425）。在第二阶段试验中，胸腔引流量的中位数为690ml（500-1880，n=15）。在II期单臂试验中，输注室温储存与非并行低温储存8-14天血小板之间的胸水引流量中位数差异为30mL（95％CI，-1040，355）。体外输注室温和低温储存的血小板会增加输注后血小板的聚集。本研究认为输注低温储存或室温储存血小板患者的总血液使用量、不良事件的发生量、重症监护病房的住院时间以及死亡率是相似的。
结论：该初步试验结果证实了输注低温储存14天内血小板止血潜力的可行性，这为在心胸手术高风险出血患者中将来进行试验提供了重要指导。
A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery.
BACKGROUND: This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials.
METHODS: A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality.
RESULTS: In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature-stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature- and cold-stored up to 7 days arm was 75 ml (95% CI, -220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, -1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature- and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
CONCLUSIONS: This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients.
翻译：易菁
编辑：佟睿
审校：曹莹
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