An observational study in Blood Loss Anemia, sponsored by Population Health Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-17.
Sponsored by Population Health Research Institute · Observational
STRATUS will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. This is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.
The STRATUS Pilot Study is a prospective observational study (before-after design) to assess the feasibility of implementing a full-scale randomized trial powered for clinical outcomes (RBC transfusion, incidence and severity of anemia). Identification of barriers and facilitators of implementation will enhance the conduct of the full-scale trial and facilitate incorporation of the intervention into routine practice.
All adult patients admitted to the participating intensive care unit at the investigative site.
Investigative Site Eligibility:
Use of standard-volume blood collection tubes (6 weeks)
Device: Standard-Volume
Use of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period)
Device: Small-Volume
Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
Successful crossover from standard-volume to small-volume tubes
Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period
Time frame: 2 week washout period
Adherence to the correct tube size during the intervention period
Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area
Time frame: 6 week intervention period
Sufficient volume for testing with small-volume tubes
Defined as \<3% of samples reported as inadequate volume for testing
Time frame: 6 week intervention period
Acceptability of the intervention by end-users
Acceptability qualitatively evaluated during structured focus group discussions
Time frame: 6 week intervention period
Complete primary data collection
Defined as at least 95% of patients with complete data collected
Time frame: 14 weeks
Reduction in blood loss
Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes.
Time frame: 12 weeks
RBC units transfused
Number of RBC units transfused per patient-day in the ICU.
Time frame: 12 weeks
Change in hemoglobin
Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion.
Time frame: 12 weeks
ICU and hospital length of stay
ICU and hospital length of stay
Time frame: 12 weeks
ICU and hospital mortality
ICU and in-hospital mortality
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Population Health Research Institute