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

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ClinicalTrials.gov Identifier: NCT03578419
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE July 6, 2018
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03578419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • 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
  • 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
  • ICU and hospital mortality [ Time Frame: through study completion, an average of 1.5 years ]
    Mortality rates in the ICU and hospital
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Small-Volume Tubes to Reduce Anemia and Transfusion
Official Title  ICMJE Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Blood Loss Anemia
Intervention  ICMJE
  • Device: Small-Volume Blood Collection Tubes
    Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
  • Device: Standard-Volume Blood Collection Tubes
    Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
Study Arms  ICMJE
  • Active Comparator: Control Period
    Standard-Volume Blood Collection Tubes
    Intervention: Device: Standard-Volume Blood Collection Tubes
  • Experimental: Intervention Period
    Small-Volume Blood Collection Tubes ("soft-draw")
    Intervention: Device: Small-Volume Blood Collection Tubes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2018)
10000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

ICUs will be eligible if they meet the following criteria:

  1. Large size ICU (at least 14 level 2-3 ICU beds) with capacity for invasive mechanical ventilation
  2. Use BD Vacutainer® blood collection tubes
  3. Use standard-draw tubes for blood sampling in adults
  4. Electronic information is available for extraction of administrative and health record data
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: STRATUS Coordinator 9055212100 ext 40329 stratus@phri.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03578419
Other Study ID Numbers  ICMJE STRATUS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah Siegal, MD MSc FRCPC Population Health Research Institute; McMaster University
Study Chair: Stuart Connolly, MD Population Health Research Institute; McMaster University
PRS Account Population Health Research Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP