Randomized Trial of Platelet-Transfusion Thresholds in Neonates
Randomized Trial of Platelet-Transfusion Thresholds in Neonates
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DOI：
10.1056/nejmoa1807320
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发表时间：
2019-01-17
影响因子：
158.5
通讯作者：
Watts, Timothy
中科院分区：
文献类型：
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作者：
Curley, Anna;Stanworth, Simon J.;Watts, Timothy
背景血小板输注通常用于预防患有血小板减少症的早产儿出血。缺乏数据来指导患有严重血小板减少症的早产儿预防性血小板输注的阈值。方法在这项多中心试验中，我们随机分配妊娠不足 34 周出生、出现严重血小板减少症的婴儿接受血小板计数阈值为 50,000/立方毫米的血小板输注（高阈值组） 或每立方毫米 25,000 个（低阈值组）。使用经过验证的出血评估工具前瞻性地记录出血情况。主要结局是随机分组后 28 天内死亡或新发大出血。 结果 共有 660 名婴儿（中位出生体重，740 克；中位胎龄，26.6 周）接受了随机分组。在高阈值组中，90% 的婴儿（328 名婴儿中的 296 名）接受了至少一次血小板输注，而低阈值组中这一比例为 53%（331 名婴儿中的 177 名）。高阈值组中 26% 的婴儿（324 名中的 85 名）发生新的大出血事件或死亡，低阈值组中这一比例为 19%（329 名中的 61 名）（比值比，1.57；95% 置信区间 [CI]，1.06 至 2.32；P = 0.02）。各组之间的严重不良事件发生率没有显着差异（高阈值组为 25%，低阈值组为 22%；比值比为 1.14；95% CI，0.78 至 1.67）。 结论 在患有严重血小板减少症的早产儿中，随机分配接受血小板计数阈值为 50,000/立方毫米的血小板输注的早产儿的不良事件发生率 随机分组后 28 天内的死亡率或大出血率明显高于接受血小板计数阈值为 25,000/立方毫米的血小板输注的患者。
BACKGROUNDPlatelet transfusions are commonly used to prevent bleeding in preterm infants with thrombocytopenia. Data are lacking to provide guidance regarding thresholds for prophylactic platelet transfusions in preterm neonates with severe thrombocytopenia.METHODSIn this multicenter trial, we randomly assigned infants born at less than 34 weeks of gestation in whom severe thrombocytopenia developed to receive a platelet transfusion at platelet-count thresholds of 50,000 per cubic millimeter (high-threshold group) or 25,000 per cubic millimeter (low-threshold group). Bleeding was documented prospectively with the use of a validated bleeding-assessment tool. The primary outcome was death or new major bleeding within 28 days after randomization.RESULTSA total of 660 infants (median birth weight, 740 g; and median gestational age, 26.6 weeks) underwent randomization. In the high-threshold group, 90% of the infants (296 of 328 infants) received at least one platelet transfusion, as compared with 53% (177 of 331 infants) in the low-threshold group. A new major bleeding episode or death occurred in 26% of the infants (85 of 324) in the high-threshold group and in 19% (61 of 329) in the low-threshold group (odds ratio, 1.57; 95% confidence interval [CI], 1.06 to 2.32; P = 0.02). There was no significant difference between the groups with respect to rates of serious adverse events (25% in the highthreshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67).CONCLUSIONSAmong preterm infants with severe thrombocytopenia, those randomly assigned to receive platelet transfusions at a platelet-count threshold of 50,000 per cubic millimeter had a significantly higher rate of death or major bleeding within 28 days after randomization than those who received platelet transfusions at a plateletcount threshold of 25,000 per cubic millimeter.