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Pathology and Laboratory Medicine

Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive CareThe STRATUS Randomized Clinical Trial

Educational Objective: To identify the key insights or developments described in this article.

1 Credit CME

JAMA

Published Online: October 12, 2023

Original Investigation

Article Information and Disclosures

Deborah M. Siegal, MD^1,2,3,4;

Emilie P. Belley-Côté, MD, PhD^1,2,8;

Shun Fu Lee, PhD^1,8;

Stephen Hill, MD, PhD⁵;

Frédérick D’Aragon, MD⁶;

Ryan Zarychanski, MD⁷;

Bram Rochwerg, MD^2,8;

Michaël Chassé, MD, PhD⁹;

Alexandra Binnie, MD, DPhil¹⁰;

Kimia Honarmand, MD¹¹;

François Lauzier, MD¹²;

Ian Ball, MD¹¹;

Waleed Al-Hazzani, MD^2,13;

Patrick Archambault, MD¹⁴;

Erick Duan, MD^2,15;

Kosar Khwaja, MD¹⁶;

François Lellouche, MD, PhD¹⁷;

Paul Lysecki, MD¹⁸;

François Marquis, MD²²;

Jean-François Naud, MD¹⁹;

Jason Shahin, MD, MSc²⁰;

Jennifer Shea, PhD²¹;

Jennifer L.Y. Tsang, MD, PhD^2,15;

Han Ting Wang, MD²²;

Mark Crowther, MD^2,13;

Donald M. Arnold, MD²;

Emily Di Sante, MA¹;

Gladys Marfo, BSc¹;

Tanya Kovalova, MMath¹;

Sylvanus Fonguh, MSc¹;

Jessica Vincent, MSc¹;

Stuart J. Connolly, MD^1,2

Author Affiliations

¹Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
²Department of Medicine, McMaster University, Hamilton, Ontario, Canada
³Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
⁴Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
⁵Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada
⁶Department of Anesthesiology, Université de Sherbrooke, Sherbrooke, Québec, Canada
⁷Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
⁸Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
⁹Centre Hospitalier de l’Université de Montréal, Department of Medicine, Université de Montréal, Montréal, Québec, Canada
¹⁰William Osler Health System – Brampton Civic and Etobicoke General, Brampton, Ontario, Canada
¹¹London Health Sciences Centre – CCTC and University Hospital, Department of Medicine, Western University, London, Ontario, Canada
¹²Centre Hospitalier Universitaire de Québec - Enfant-Jésus and Hôtel-Dieu, Department of Medicine, Department of Anesthesiology, Université Laval, Québec, Canada
¹³St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada
¹⁴Hôtel-Dieu de Lévis, Department of Family Medicine and Urgent Care, Université Laval, Québec, Canada
¹⁵Niagara Health – St. Catharine’s General Hospital, St. Catharine’s, Ontario, Canada
¹⁶Montreal General Hospital, Departments of Surgery and Critical Care Medicine, McGill University, Montréal, Québec, Canada
¹⁷Institut Universitaire de Cardiologie et de Pneumologie de Québec, Department of Medicine, Université Laval, Québec, Canada
¹⁸Joseph Brant Hospital, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
¹⁹Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec-CHAUR, Trois-Rivières, Québec, Canada
²⁰Royal Victoria Hospital, Department of Critical Care, McGill University, Montréal, Québec, Canada
²¹Saint John Regional Hospital, Department of Medicine, Memorial University, St. John, New Brunswick, Canada
²²Maisonneuve-Rosemont, Department of Medicine, Université de Montréal, Montréal, Québec, Canada

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Key Points

Question Does transitioning from standard-volume to small-volume blood collection tubes for laboratory testing in intensive care units (ICUs) reduce red blood cell (RBC) transfusion?

Findings After transition to small-volume tubes in this stepped-wedge cluster randomized trial, RBC transfusion was not significantly different in the primary analysis of 21 201 patients, excluding 6210 admitted during the COVID-19 pandemic (relative risk, 0.91), but it was significantly lower in the secondary analysis of all 27 411 patients (RR, 0.88; absolute decrease, 9.84 RBC units/100 patients). The frequency of insufficient specimens was not different (≤0.03%).

Meaning Small-volume blood collection tubes in the ICU may decrease RBC transfusions without affecting laboratory analysis.

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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Article Information

Accepted for Publication: September 22, 2023.

Published Online: October 12, 2023. doi:10.1001/jama.2023.20820

Corresponding Author: Deborah M. Siegal, MD, MSc, Ottawa Blood Diseases Centre and Ottawa Hospital Research Institute, Department of Medicine, The Ottawa Hospital, 501 Smyth Rd, Box 201A, Ottawa, ON, Canada, K1H 8L6 (dsiegal@toh.ca).

Author Contributions: Drs Siegal, Belley-Côté, and Leehad full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Siegal, Belley-Côté, Lee, Hill, D'Aragon, Zarychanski, Rochwerg, Crowther, Arnold, Vincent, Connolly.

Acquisition, analysis, or interpretation of data: Siegal, Belley-Côté, Lee, Hill, D'Aragon, Zarychanski, Chassé, Binnie, Honarmand, Lauzier, Ball, Al-Hazzani, Archambault, Duan, Khwaja, Lellouche, Lysecki, Marquis, Naud, Shahin, Shea, Tsang, Wang, Arnold, Di Sante, Marfo, Kovalova, Fonguh, Connolly.

Drafting of the manuscript: Siegal, Belley-Côté, Lee, Hill, Zarychanski, Lauzier, Shea, Crowther, Di Sante, Marfo, Kovalova, Connolly.

Critical review of the manuscript for important intellectual content: Belley-Côté, Lee, Hill, D'Aragon, Zarychanski, Rochwerg, Chassé, Binnie, Honarmand, Lauzier, Ball, Al-Hazzani, Archambault, Duan, Khwaja, Lellouche, Lysecki, Marquis, Naud, Shahin, Shea, Tsang, Wang, Arnold, Di Sante, Fonguh, Vincent, Connolly.

Statistical analysis: Lee, Kovalova, Fonguh.

Obtained funding: Siegal, Duan, Crowther.

Administrative, technical, or material support: Hill, D'Aragon, Zarychanski, Rochwerg, Chassé, Binnie, Honarmand, Lauzier, Ball, Archambault, Duan, Lellouche, Lysecki, Naud, Shahin, Shea, Tsang, Wang, Crowther, Arnold, Di Sante, Marfo, Vincent.

Supervision: Belley-Côté, Lee, D'Aragon, Chassé, Lauzier, Archambault, Duan, Khwaja, Lellouche, Lysecki, Naud, Crowther, Arnold, Connolly.

Other - Held responsibility (as local primary investigator) for one of the hospitals involved in the trial, coordinated/arranged the trial at this site, and supervised the proper conduct of the trial (ie, troubleshooting, data collection, etc at the CIUSSS MCQ CHAUR in Trois-Rivières, québec): Naud.

Other - trial management: Di Sante.

Other: - Principal investigator responsible for all study activities at his site: Al-Hazzani.

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.

Funding/Support: This study was funded by a peer-reviewed grant from Academic Health Sciences Centers AFP Innovation Fund/Hamilton Academic Health Sciences Organization (HAHSO) and Hamilton Health Sciences Research Institute through the Population Health Research Institute. Dr Siegal is supported by a Tier 2 Canada Research Chair in Anticoagulant Management of Cardiovascular Disease. Dr Belley-Côté is supported by a National New Investigator Award from the Heart and Stroke Foundation of Canada.

Role of the Funder/Sponsor: HAHSO had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.