Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS)
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|ClinicalTrials.gov Identifier: NCT03578419|
Recruitment Status : Active, not recruiting
First Posted : July 6, 2018
Last Update Posted : May 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Blood Loss Anemia||Device: Small-Volume Blood Collection Tubes Device: Standard-Volume Blood Collection Tubes||Not Applicable|
Blood sampling can cause significant unnecessary blood loss particularly in the intensive care unit (ICU). Blood loss contributes to anemia which is highly prevalent in the ICU and is associated with major adverse cardiovascular outcomes and death. Red blood cell (RBC) transfusions to correct anemia also have significant health risks.
Using a stepped wedge cluster randomized trial design, the specific aim of the STRATUS study is to evaluate whether the routine use of small-volume blood collection tubes reduces RBC transfusion compared to standard-volume blood collection tubes in adult ICU patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10000 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A stepped wedge cluster randomized trial in which ICUs (clusters) switch from a strategy of blood collection using standard-draw tubes (control) to soft-draw tubes (intervention). In this design, the timing at which individual ICUs switch to the intervention is randomly assigned.|
|Masking:||None (Open Label)|
|Official Title:||Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial|
|Actual Study Start Date :||January 1, 2019|
|Actual Primary Completion Date :||January 21, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Active Comparator: Control Period
Standard-Volume Blood Collection Tubes
Device: Standard-Volume Blood Collection Tubes
Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
Experimental: Intervention Period
Small-Volume Blood Collection Tubes ("soft-draw")
Device: Small-Volume Blood Collection Tubes
Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
- RBC Transfusions [ Time Frame: through study completion, an average of 1.5 years ]Average number of red blood cell (RBC) units transfused per patient during ICU admission among patients admitted to ICU for 48 hours or longer.
- Hemoglobin Concentration [ Time Frame: through study completion, an average of 1.5 years ]Change in hemoglobin concentration from ICU admission to ICU discharge adjusted for number of RBC transfusions received
- ICU and hospital length of stay [ Time Frame: through study completion, an average of 1.5 years ]Length of stay in the ICU and hospital
- ICU and hospital mortality [ Time Frame: through study completion, an average of 1.5 years ]Mortality rates in the ICU and hospital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578419
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Deborah Siegal, MD MSc FRCPC||Population Health Research Institute; McMaster University|
|Study Chair:||Stuart Connolly, MD||Population Health Research Institute; McMaster University|