Blood Loss Anemia
Conditions
Keywords
Anemia, Blood transfusion, Intensive Care Unit, Blood sampling, Stepped wedge, Red blood cells
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
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.
Interventions
DEVICESmall-Volume Blood Collection Tubes
Small-volume vacuum (\< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
DEVICEStandard-Volume Blood Collection Tubes
Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ICUs will be eligible if they meet the following criteria: 1. Adult ICU 2. At least 14 level 2-3 ICU beds with capacity for invasive mechanical ventilation 3. Use of vacuum tubes for routine blood collection 4. Able to achieve at least 25% estimated reduction in blood volume by switching to small-volume vacuum tubes 5. Electronic administrative and health record data available for data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC Transfusions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Concentration | 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 | through study completion, an average of 1.5 years | Length of stay in the ICU and hospital |
| ICU and hospital mortality | through study completion, an average of 1.5 years | Mortality rates in the ICU and hospital |
Countries
Canada
Outcome results
None listed