Back to resultsSmall-Volume Tubes to Reduce Anemia and Transfusion (STRATUS)
Primary Purpose
Blood Loss Anemia
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Small-Volume Blood Collection Tubes
Standard-Volume Blood Collection Tubes
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss Anemia focused on measuring Anemia, Blood transfusion, Intensive Care Unit, Blood sampling, Stepped wedge, Red blood cells
Eligibility Criteria
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
Sites / Locations
- University of Manitoba - Health Sciences Centre
- Saint John Regional Hospital
- William Osler Health System - Brampton Civic
- Joseph Brant Hospital
- William Osler Health System - Etobicoke General
- Hamilton General Hospital
- Juravinski Cancer Centre
- St. Joseph's Hospital
- London Health Sciences Centre - CCTC
- London Health Sciences Centre - University Hospital
- St. Catharine's General Hospital
- Hôtel-Dieu de Lévis
- CHUM - AB cardiothoracic
- CHUM - CD transplants/surgical ICU
- CHUM - EF neuro ICU
- Maisonneuve-Rosemont
- Royal Victoria Hospital
- Montreal General Hospital
- CHU de Quebec - Enfant-Jésus
- Universite de Sherbrooke - Hopital Fleurimont
- Universite de Sherbrooke - Hôtel-Dieu
- Ciuss-McQ-Chaur
- CHU de Quebec - Hotel Dieu
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Period
Intervention Period
Arm Description
Standard-Volume Blood Collection Tubes
Small-Volume Blood Collection Tubes ("soft-draw")
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hemoglobin Concentration
Change in hemoglobin concentration from ICU admission to ICU discharge adjusted for number of RBC transfusions received
ICU and hospital length of stay
Length of stay in the ICU and hospital
ICU and hospital mortality
Mortality rates in the ICU and hospital
Full Information
NCT ID
NCT03578419
First Posted
June 21, 2018
Last Updated
June 19, 2023
Sponsor
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03578419
Brief Title
Small-Volume Tubes to Reduce Anemia and Transfusion
Acronym
STRATUS
Official Title
Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss Anemia
Keywords
Anemia, Blood transfusion, Intensive Care Unit, Blood sampling, Stepped wedge, Red blood cells
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Period
Arm Type
Active Comparator
Arm Description
Standard-Volume Blood Collection Tubes
Arm Title
Intervention Period
Arm Type
Experimental
Arm Description
Small-Volume Blood Collection Tubes ("soft-draw")
Intervention Type
Device
Intervention Name(s)
Small-Volume Blood Collection Tubes
Intervention Description
Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
Intervention Type
Device
Intervention Name(s)
Standard-Volume Blood Collection Tubes
Intervention Description
Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
Primary Outcome Measure Information:
Title
RBC Transfusions
Description
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 Outcome Measure Information:
Title
Hemoglobin Concentration
Description
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
Title
ICU and hospital length of stay
Description
Length of stay in the ICU and hospital
Time Frame
through study completion, an average of 1.5 years
Title
ICU and hospital mortality
Description
Mortality rates in the ICU and hospital
Time Frame
through study completion, an average of 1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Siegal, MD MSc FRCPC
Organizational Affiliation
Population Health Research Institute; McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Connolly, MD
Organizational Affiliation
Population Health Research Institute; McMaster University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Manitoba - Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
William Osler Health System - Brampton Civic
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Joseph Brant Hospital
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
William Osler Health System - Etobicoke General
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre - CCTC
City
London
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
St. Catharine's General Hospital
City
Saint Catherines
State/Province
Ontario
Country
Canada
Facility Name
Hôtel-Dieu de Lévis
City
Lévis
State/Province
Quebec
Country
Canada
Facility Name
CHUM - AB cardiothoracic
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHUM - CD transplants/surgical ICU
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHUM - EF neuro ICU
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
CHU de Quebec - Enfant-Jésus
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
Universite de Sherbrooke - Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Universite de Sherbrooke - Hôtel-Dieu
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Ciuss-McQ-Chaur
City
Trois-Rivières
State/Province
Quebec
Country
Canada
Facility Name
CHU de Quebec - Hotel Dieu
City
Quebec
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Small-Volume Tubes to Reduce Anemia and Transfusion
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