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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

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.

Condition or disease Intervention/treatment Phase
Blood Loss Anemia Device: Small-Volume Blood Collection Tubes Device: Standard-Volume Blood Collection Tubes Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
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
Official Title: Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Period
Standard-Volume Blood Collection 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.

Experimental: Intervention Period
Small-Volume Blood Collection Tubes ("soft-draw")
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578419


Contacts
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Contact: STRATUS Coordinator 9055212100 ext 40329 stratus@phri.ca

Locations
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Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Stratus Study Coordinator, MD    9055212100    stratus@phri.ca   
Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Deborah Siegal, MD MSc FRCPC Population Health Research Institute; McMaster University
Study Chair: Stuart Connolly, MD Population Health Research Institute; McMaster University

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03578419     History of Changes
Other Study ID Numbers: STRATUS
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
Anemia
Blood transfusion
Intensive Care Unit
Blood sampling
Stepped wedge
Red blood cells
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases