Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Novo Nordisk Foundation Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; and.
Blood. 2022 Jun 23;139(25):3647-3654. doi: 10.1182/blood.2022015892.
Randomized controlled trials (RCTs) have found no evidence that the storage time of transfused red blood cell (RBC) units affects recipient survival. However, inherent difficulties in conducting RBC transfusion RCTs have prompted critique of their design, analyses, and interpretation. Here, we address these issues by emulating hypothetical randomized trials using large real-world data to further clarify the adverse effects of storage time. We estimated the comparative effect of transfusing exclusively older vs fresher RBC units on the primary outcome of death, and the secondary composite end point of thromboembolic events, or death, using inverse probability weighting. Thresholds were defined as 1, 2, 3, and 4 weeks of storage. A large Danish blood transfusion database from the period 2008 to 2018 comprising >900 000 transfusion events defined the observational data. A total of 89 799 patients receiving >340 000 RBC transfusions during 28 days of follow-up met the eligibility criteria. Treatment with RBC units exclusively fresher than 1, 2, 3, and 4 weeks of storage was found to decrease the 28-day recipient mortality with 2.44 percentage points (pp) (0.86 pp, 4.02 pp), 1.93 pp (0.85 pp, 3.02 pp), 1.06 pp (-0.20 pp, 2.33 pp), and -0.26 pp (-1.78 pp, 1.25 pp) compared with transfusing exclusively older RBC units, respectively. The 28-day risk differences for the composite end point were similar. This study suggests that transfusing exclusively older RBC units stored for >1 or 2 weeks increases the 28-day recipient mortality and risk of thromboembolism or death compared with transfusing fresher RBC units.
随机对照试验（RCT）并未发现输存储时间的红细胞（RBC）单位会影响受者的生存。然而，由于 RBC 输血 RCT 固有设计的困难，促使人们对其设计、分析和解释提出了批评。在这里，我们通过使用大型真实世界的数据模拟假设的随机试验来解决这些问题，以进一步阐明存储时间的不良影响。我们使用逆概率加权来估计专门输注较旧或更新鲜 RBC 单位对主要结局（死亡）和次要复合终点（血栓栓塞事件或死亡）的比较效果。阈值定义为 1、2、3 和 4 周的储存时间。2008 年至 2018 年期间，丹麦一个大型输血数据库包含超过 90 万次输血事件，定义了观察性数据。在 28 天的随访期间，共有 89799 名接受超过 340000 单位 RBC 输血的患者符合入选标准。发现与专门输注较旧的 RBC 单位相比，专门输注较新鲜（<1、2、3 和 4 周）的 RBC 单位可将 28 天的受者死亡率降低 2.44 个百分点（pp）（0.86 pp，4.02 pp）、1.93 pp（0.85 pp，3.02 pp）、1.06 pp（-0.20 pp，2.33 pp）和-0.26 pp（-1.78 pp，1.25 pp）。28 天复合终点的风险差异相似。这项研究表明，与输注更新鲜的 RBC 单位相比，专门输注储存时间超过 1 或 2 周的较旧 RBC 单位会增加 28 天的受者死亡率和血栓栓塞或死亡的风险。
