Small-Volume Tubes to Reduce Anemia and Transfusion

Population Health Research Institute27,411 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

27,411

Conditions

Blood Loss Anemia

Interventions

Small-Volume Blood Collection TubesDEVICE

Small-volume vacuum (\< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.

Standard-Volume Blood Collection TubesDEVICE

Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

RBC Transfusions

Average number of red blood cell (RBC) units transfused per patient during ICU admission among patients admitted to ICU for 48 hours or longer.

Time frame: through study completion, an average of 1.5 years

Secondary Outcomes

Hemoglobin Concentration

Change in hemoglobin concentration from ICU admission to ICU discharge adjusted for number of RBC transfusions received

Time frame: through study completion, an average of 1.5 years

ICU and hospital length of stay

Length of stay in the ICU and hospital

Time frame: through study completion, an average of 1.5 years

ICU and hospital mortality

Mortality rates in the ICU and hospital

Time frame: through study completion, an average of 1.5 years

Data from ClinicalTrials.gov

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