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Completed

NCT Number: NCT03284944

Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS)

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Small-Volume

Device

Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Standard-Volume

Device

Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Primary outcomes

  1. Successful crossover from standard-volume to small-volume tubes

    Time frame: 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

  2. Adherence to the correct tube size during the intervention period

    Time frame: 6 week intervention period

    Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area

  3. Sufficient volume for testing with small-volume tubes

    Time frame: 6 week intervention period

    Defined as <3% of samples reported as inadequate volume for testing

  4. Acceptability of the intervention by end-users

    Time frame: 6 week intervention period

    Acceptability qualitatively evaluated during structured focus group discussions

  5. Complete primary data collection

    Time frame: 14 weeks

    Defined as at least 95% of patients with complete data collected

Secondary outcomes

  1. Reduction in blood loss

    Time frame: 12 weeks

    Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes.

  2. RBC units transfused

    Time frame: 12 weeks

    Number of RBC units transfused per patient-day in the ICU.

  3. Change in hemoglobin

    Time frame: 12 weeks

    Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion.

  4. ICU and hospital length of stay

    Time frame: 12 weeks

    ICU and hospital length of stay

  5. ICU and hospital mortality

    Time frame: 12 weeks

    ICU and in-hospital mortality

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS): A Pilot Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2017
Registry last updated
Sep 17, 2020

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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