Exemplar Trial Overview - STRATUS. (15-min video & 25-slide presentation)

• Summary: Blood collection for laboratory testing in intensive care units is a modifiable contributor to anemia and red blood cell transfusion; a substantial amount of withdrawn blood is not required for analysis and is discarded. Dr. Deborah Siegal overviews a pragmatic, multicentre, stepped-wedge, cluster randomized trial (Small-Volume Tubes to Reduce Anemia and Transfusion: STRATUS) to evaluate the effect of transitioning from standard-volume to small-volume blood collection vacuum tubes for all blood collection (except blood cultures and blood gases).

Siegal DM, et al. Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1872-1881. (10-page paper)

• Summary: Routine use of small-volume tubes could reduce iatrogenic blood loss. However, small-volume tubes are not considered standard of care, nor are they specifically recommended by practice guidelines. This may be due, at least in part, to a lack of robust evidence showing that transitioning to small-volume tubes improves clinical outcomes. This publication in JAMA describes the STRATUS pragmatic, multicentre, stepped-wedge, cluster randomized trial in which answered the question: “Does transitioning from standard-volume to small-volume blood collection tubes for laboratory testing in intensive care units reduce red blood cell transfusion?”

Exemplar Trial - STRATUS. (16-min video & 31-slide presentation)

• Summary: Dr. Deborah Siegal breaks down the STRATUS pragmatic trial across sections of the curriculum wheel.

Siegal DM, et al. Small-volume tubes to reduce anemia and transfusion (STRATUS): a pilot study. Can J Anaesth. 2023 Nov;70(11):1797-1806. (10-page paper)

• Summary: A pilot study describing the feasibility of a stepped-wedge cluster trial to determine whether small-volume tubes reduce transfusion compared with standard-volume tubes in intensive care unit patients. Feasibility was assessed as successful switch to small-volume tubes, adherence to tube size, sufficient volume for testing, user acceptance, barriers and facilitators to implementation, and 95% transfusion collection. Focus groups were also used to explore end-user acceptability.

Siegal DM, et al. Supplement 2 - Trial Protocol and Statistical Analysis Plan - Published alongside the main trial: JAMA. 2023 Nov 21;330(19):1872-1881. (35-page supplementary material)

• Summary: Describes the trial protocol and statistical analysis plan for the STRATUS trial, a pragmatic, multicentre, stepped-wedge, cluster randomized trial.

Small-Volume Blood Collection Tubes May Reduce Transfusions in Intensive Care (JN Learning - Pathology and Laboratory Medicine) (November 21, 2023): 17-min interview.

• Summary: JAMA Associate Editor Dr. Christopher Seymour discusses the results and implications of the STRATUS trial with Dr. Deborah Siegal (lead author) of the Ottawa Hospital Research Institute.

Small-volume Blood Collection Tubes (November 22, 2023 via "JAMA Network"): 1-min video.

• Summary: A one-minute “short” video describing the rationale and findings of the STRATUS trial.

Callum J, et al. Small-volume blood sample collection tubes in adult intensive care units: A rapid practice guideline. Acta Anaesthesiol Scand. 2024 Nov;68(10):1319-1326. (8-page paper)

• Summary: Describes the Intensive Care Medicine Rapid Practice Guideline (ICM-RPG) which overviews the published evidence related to the use of small-volume collection tubes; recommendations for clinical practice, based on this evidence, are then provided. The STRATUS pragmatic trial was a key piece of evidence that was summarized in the review, and the results of the trial supported the recommendation to use small-volume blood collection tubes over conventional blood collection tubes in adult intensive care units.

Siegal DM, et al. Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS). ClinicalTrials.gov identifier: NCT03578419. Updated 2024-07-01. (8-section website)

• Summary: Public registration of the trial (i.e., study overview, contacts and locations, study plan, collaborators and investigators, publications, study record dates).