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Completed

NCT Number: NCT03578419

Small-Volume Tubes to Reduce Anemia and Transfusion

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.

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Key information

Conditions

Blood Loss Anemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba - Health Sciences Centre, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

ICUs will be eligible if they meet the following criteria:

  • Adult ICU
  • At least 14 level 2-3 ICU beds with capacity for invasive mechanical ventilation
  • Use of vacuum tubes for routine blood collection
  • Able to achieve at least 25% estimated reduction in blood volume by switching to small-volume vacuum tubes
  • Electronic administrative and health record data available for data collection

Treatment and study plan

Small-Volume Blood Collection Tubes

Device

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

Standard-Volume Blood Collection Tubes

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. ICU and hospital mortality

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

    Mortality rates in the ICU and hospital

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial

Acronym: STRATUS

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Jul 6, 2018
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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