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Randomized Controlled Trial
. 2023 Nov 21;330(19):1872-1881.
doi: 10.1001/jama.2023.20820.

Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial

Deborah M Siegal  1   2   3   4 , Emilie P Belley-Côté  1   2   5 , Shun Fu Lee  1   5 , Stephen Hill  6 , Frédérick D'Aragon  7 , Ryan Zarychanski  8 , Bram Rochwerg  2   5 , Michaël Chassé  9 , Alexandra Binnie  10 , Kimia Honarmand  11 , François Lauzier  12 , Ian Ball  11 , Waleed Al-Hazzani  2   13 , Patrick Archambault  14 , Erick Duan  2   15 , Kosar Khwaja  16 , François Lellouche  17 , Paul Lysecki  18 , François Marquis  19 , Jean-François Naud  20 , Jason Shahin  21 , Jennifer Shea  22 , Jennifer L Y Tsang  2   15 , Han Ting Wang  19 , Mark Crowther  2   13 , Donald M Arnold  2 , Emily Di Sante  1 , Gladys Marfo  1 , Tanya Kovalova  1 , Sylvanus Fonguh  1 , Jessica Vincent  1 , Stuart J Connolly  1   2
Affiliations
Randomized Controlled Trial

Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial

Deborah M Siegal et al. JAMA. .

Abstract

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 Most blood withdrawn is not required for analysis and is discarded.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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Siegal reported personal fees (honoraria for presentations paid indirectly to her institution) from BMS-Pfizer, AstraZeneca, Servier, and Roche outside the submitted work. Dr Belley-Côté reported grants from Roche Diagnostics and Bayer; and personal fees from Trimedic Therapeutics outside the submitted work. Dr Lauzier reported grants from the Canadian Institute of Health Research (CIHR) and other from Fonds de recherche du Québec-Santé Career Award outside the submitted work. Dr Archambault reported receiving funding from the Fonds de recherche du Québec-Santé for a Senior Clinical Scholar Award. Dr Lellouche reported grants from CIHR during the conduct of the study; other from Oxynov (shareholder) outside the submitted work; and holding a patent for automated oxygen titration with royalties paid. Dr Shea reported grants and personal fees from Becton Dickinson outside the submitted work. Dr Tsang reported other from McMaster University (site initiation fee plus per-patient fee to support the staff to enroll patients into this study) during the conduct of the study. Dr Crowther reported personal fees (advisory boards and educational materials) from AstraZeneca, Bayer, Pfizer, CSL Behring, Hemostasis Reference Laboratories, Syneos Health, and Eversana outside the submitted work; participation in various medicolegal matters related to care and control of anticoagulation and hematology; and receipt of payments from a variety of not-for-profit and for-profit agencies for various projects related to anticoagulation and hematology. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, ICU Randomization, and Patient Flow in the STRATUS Trial
Numeric values in each cell indicate the number of patients and the mean (SD) size of included clusters. ICU indicates intensive care unit.
Figure 2.
Figure 2.. RBC Units per Patient per ICU Stay Before and After Transition to Small-Volume Tubes at Individual ICUs (Primary Population)
aRelative risk (RR) is adjusted for age and sex. Plot shows the mean (95% CI) number of red blood cell (RBC) units per patient per median intensive care unit (ICU) stay at individual ICUs. The mean area of the squares is proportional to the corresponding total sample size of the ICU, and error bars indicate the 95% CIs. Patients admitted during the transition delay due to the COVID-19 pandemic were excluded. The square boxes denote the relative risk (RR) of RBC transfusion before and after transition to small-volume tubes adjusted for age and sex. Each ICU is represented by a single row and displayed in the order of transition to small-volume tubes.
See this image and copyright information in PMC

Comment in

  • doi: 10.1001/jama.2023.21801

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