小容量采血管减少重症监护输血：STRATUS 随机临床试验。
Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial.
机构信息
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
出版信息
JAMA. 2023 Nov 21;330(19):1872-1881. doi: 10.1001/jama.2023.20820.
IMPORTANCE
Blood collection for laboratory testing in intensive care unit (ICU) patients is a modifiable contributor to anemia and red blood cell (RBC) transfusion. Most blood withdrawn is not required for analysis and is discarded.
OBJECTIVE
To determine whether transitioning from standard-volume to small-volume vacuum tubes for blood collection in ICUs reduces RBC transfusion without compromising laboratory testing procedures.
DESIGN, SETTING, AND PARTICIPANTS: Stepped-wedge cluster randomized trial in 25 adult medical-surgical ICUs in Canada (February 5, 2019 to January 21, 2021).
INTERVENTIONS
ICUs were randomized to transition from standard-volume (n = 10 940) to small-volume tubes (n = 10 261) for laboratory testing.
MAIN OUTCOMES AND MEASURES
The primary outcome was RBC transfusion (units per patient per ICU stay). Secondary outcomes were patients receiving at least 1 RBC transfusion, hemoglobin decrease during ICU stay (adjusted for RBC transfusion), specimens with insufficient volume for testing, length of stay in the ICU and hospital, and mortality in the ICU and hospital. The primary analysis included patients admitted for 48 hours or more, excluding those admitted during a 5.5-month COVID-19-related trial hiatus.
RESULTS
In the primary analysis of 21 201 patients (mean age, 63.5 years; 39.9% female), which excluded 6210 patients admitted during the early COVID-19 pandemic, there was no significant difference in RBC units per patient per ICU stay (relative risk [RR], 0.91 [95% CI, 0.79 to 1.05]; P = .19; absolute reduction of 7.24 RBC units/100 patients per ICU stay [95% CI, -3.28 to 19.44]). In a prespecified secondary analysis (n = 27 411 patients), RBC units per patient per ICU stay decreased after transition from standard-volume to small-volume tubes (RR, 0.88 [95% CI, 0.77 to 1.00]; P = .04; absolute reduction of 9.84 RBC units/100 patients per ICU stay [95% CI, 0.24 to 20.76]). Median decrease in transfusion-adjusted hemoglobin was not statistically different in the primary population (mean difference, 0.10 g/dL [95% CI, -0.04 to 0.23]) and lower in the secondary population (mean difference, 0.17 g/dL [95% CI, 0.05 to 0.29]). Specimens with insufficient quantity for analysis were rare (≤0.03%) before and after transition.
CONCLUSIONS AND RELEVANCE
Use of small-volume blood collection tubes in the ICU may decrease RBC transfusions without affecting laboratory analysis.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03578419.
重要性：在重症监护病房（ICU）患者中进行血液采集用于实验室检测是导致贫血和红细胞（RBC）输血的一个可改变的因素。大多数采集的血液都不需要用于分析并被丢弃。
目的：确定在 ICU 中从标准容量管过渡到小容量真空采血管是否会减少 RBC 输血，同时不影响实验室检测程序。
设计、设置和参与者：这是一项在加拿大 25 个成人内科-外科 ICU 中进行的阶梯式楔形集群随机试验（2019 年 2 月 5 日至 2021 年 1 月 21 日）。
干预措施：ICU 被随机分配从标准容量管（n = 10 940）过渡到小容量管（n = 10 261）进行实验室检测。
主要结局和措施：主要结局是 RBC 输血（每个患者每 ICU 住院的单位数）。次要结局是至少接受 1 次 RBC 输血的患者、ICU 期间血红蛋白下降（考虑 RBC 输血）、标本量不足用于检测、ICU 和医院的住院时间以及 ICU 和医院的死亡率。主要分析包括入住 ICU 48 小时或以上的患者，不包括在 COVID-19 相关试验暂停期间入住的患者。
结果：在 21 201 名患者（平均年龄 63.5 岁；39.9%为女性）的主要分析中，排除了在 COVID-19 大流行早期入住的 6210 名患者，每 ICU 住院患者的 RBC 单位数没有显著差异（相对风险 [RR]，0.91 [95% CI，0.79 至 1.05]；P = .19；每 100 名 ICU 住院患者的绝对减少量为 7.24 RBC 单位/每 ICU 住院[95% CI，-3.28 至 19.44]）。在预先指定的次要分析中（n = 27 411 名患者），从标准容量管过渡到小容量管后，每 ICU 住院患者的 RBC 单位数减少（RR，0.88 [95% CI，0.77 至 1.00]；P = .04；每 100 名 ICU 住院患者的绝对减少量为 9.84 RBC 单位/每 ICU 住院[95% CI，0.24 至 20.76]）。在主要人群中，输血调整后的血红蛋白下降无统计学差异（平均差异，0.10 g/dL [95% CI，-0.04 至 0.23]），次要人群中的下降幅度较低（平均差异，0.17 g/dL [95% CI，0.05 至 0.29]）。在转换前后，用于分析的标本量不足的情况均很少见（≤0.03%）。
结论和相关性：在 ICU 中使用小容量采血管可能会减少 RBC 输血，而不影响实验室分析。
试验注册：ClinicalTrials.gov 标识符：NCT03578419。
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