Blood Loss Anemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESmall-Volume
Small-volume (2 - 3 mL soft-draw Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
DEVICEStandard-Volume
Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
Sponsors
Population Health Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Investigative Site Eligibility: * Intensive care unit with at least 15 beds with capacity for mechanical ventilation * Current standard to use standard-draw blood collection tubes * Availability of hospital administrative data and electronic patient information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful crossover from standard-volume to small-volume tubes | 2 week washout period | Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period |
| Sufficient volume for testing with small-volume tubes | 6 week intervention period | Defined as \<3% of samples reported as inadequate volume for testing |
| Acceptability of the intervention by end-users | 6 week intervention period | Acceptability qualitatively evaluated during structured focus group discussions |
| Complete primary data collection | 14 weeks | Defined as at least 95% of patients with complete data collected |
| Adherence to the correct tube size during the intervention period | 6 week intervention period | Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in blood loss | 12 weeks | Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes. |
| RBC units transfused | 12 weeks | Number of RBC units transfused per patient-day in the ICU. |
| Change in hemoglobin | 12 weeks | Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion. |
| ICU and hospital length of stay | 12 weeks | ICU and hospital length of stay |
| ICU and hospital mortality | 12 weeks | ICU and in-hospital mortality |
Countries
Canada
Outcome results
None listed