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

June 28, 2024 updated by: Population Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

27411

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
      • Quebec, Canada
        • CHU de Quebec - Hotel Dieu
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • University of Manitoba - Health Sciences Centre
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Saint John Regional Hospital
    • Ontario
      • Brampton, Ontario, Canada
        • William Osler Health System - Brampton Civic
      • Burlington, Ontario, Canada
        • Joseph Brant Hospital
      • Etobicoke, Ontario, Canada
        • William Osler Health System - Etobicoke General
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • Hamilton, Ontario, Canada
        • St. Joseph's Hospital
      • London, Ontario, Canada
        • London Health Sciences Centre - University Hospital
      • London, Ontario, Canada
        • London Health Sciences Centre - CCTC
      • Saint Catherines, Ontario, Canada
        • St. Catharine's General Hospital
    • Quebec
      • Lévis, Quebec, Canada
        • Hotel-Dieu De Levis
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada
        • Maisonneuve-Rosemont
      • Montreal, Quebec, Canada
        • CHUM - AB cardiothoracic
      • Montreal, Quebec, Canada
        • CHUM - CD transplants/surgical ICU
      • Montreal, Quebec, Canada
        • CHUM - EF neuro ICU
      • Montréal, Quebec, Canada
        • Montreal General Hospital
      • Québec, Quebec, Canada
        • CHU de Quebec - Enfant-Jésus
      • Sherbrooke, Quebec, Canada
        • Universite de Sherbrooke - Hopital Fleurimont
      • Sherbrooke, Quebec, Canada
        • Universite de Sherbrooke - Hôtel-Dieu
      • Trois-Rivières, Quebec, Canada
        • Ciuss-McQ-Chaur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

ICUs will be eligible if they meet the following criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Period
Standard-Volume Blood Collection Tubes
Device: Standard-Volume Blood Collection Tubes
Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
Experimental: Intervention Period
Small-Volume Blood Collection Tubes ("soft-draw")
Device: Small-Volume Blood Collection Tubes
Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1.5 years
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
through study completion, an average of 1.5 years
ICU and hospital mortality
Time Frame: through study completion, an average of 1.5 years
Mortality rates in the ICU and hospital
through study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Deborah Siegal, MD MSc FRCPC, Population Health Research Institute; McMaster University
  • Study Chair: Stuart Connolly, MD, Population Health Research Institute; McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 21, 2021

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRATUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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