Blood Loss AnemiaSTRATUSNCT03578419
Small-Volume Tubes to Reduce Anemia and Transfusion
A study testing Small-Volume Blood Collection Tubes and Standard-Volume Blood Collection Tubes in people with Blood Loss Anemia, run by Population Health Research Institute at 24 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss Anemia
- What is being tested?
- Small-Volume Blood Collection Tubes and Standard-Volume Blood Collection Tubes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,411 participants
- Where
- 24 sitesCanada
- Study dates
- 1 Jan 2019to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Canada24 sites
William Osler Health System - Brampton Civic
Brampton, Ontario
Joseph Brant Hospital
Burlington, Ontario
William Osler Health System - Etobicoke General
Etobicoke, Ontario
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Juravinski Cancer Centre
Hamilton, Ontario
St. Joseph's Hospital
Hamilton, Ontario
Hôtel-Dieu de Lévis
Lévis, Quebec
London Health Sciences Centre - CCTC
London, Ontario
London Health Sciences Centre - University Hospital
London, Ontario
CHUM - AB cardiothoracic
Montreal, Quebec
CHUM - CD transplants/surgical ICU
Montreal, Quebec
CHUM - EF neuro ICU
Montreal, Quebec
Maisonneuve-Rosemont
Montreal, Quebec
Montreal General Hospital
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
CHU de Quebec - Enfant-Jésus
Québec, Quebec
CHU de Quebec - Hotel Dieu
Québec
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec
St. Catharine's General Hospital
Saint Catherines, Ontario
Saint John Regional Hospital
Saint John, New Brunswick
Universite de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec
Universite de Sherbrooke - Hôtel-Dieu
Sherbrooke, Quebec
Ciuss-McQ-Chaur
Trois-Rivières, Quebec
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Loss Anemia
- Being tested
- Small-Volume Blood Collection Tubes, Standard-Volume Blood Collection Tubes
- Keywords
- Anemia, Blood transfusion, Intensive Care Unit, Blood sampling, Stepped wedge, Red blood cells
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small-Volume Blood Collection TubesDevice
Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
Standard-Volume Blood Collection TubesDevice
Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
| Study group | Role | What they receive |
|---|---|---|
| Control Period | Active comparator | Standard-Volume Blood Collection Tubes Receives: Device: Standard-Volume Blood Collection Tubes |
| Intervention Period | Experimental | Small-Volume Blood Collection Tubes ("soft-draw") Receives: Device: Small-Volume Blood Collection Tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1.5 years
Secondary outcomes (3)
Hemoglobin Concentration
Change in hemoglobin concentration from ICU admission to ICU discharge adjusted for number of RBC transfusions received
Measured: through study completion, an average of 1.5 years
ICU and hospital length of stay
Length of stay in the ICU and hospital
Measured: through study completion, an average of 1.5 years
ICU and hospital mortality
Mortality rates in the ICU and hospital
Measured: through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jan 2019
- Primary completion21 Jan 2021
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 27,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Siegal, MD MSc FRCPC, Principal investigator, Population Health Research Institute; McMaster UniversityStuart Connolly, MD, Study chair, Population Health Research Institute; McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578419
- Sponsor's protocol ID
- STRATUS
- Acronym
- STRATUS
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2018
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siegal DM, Belley-Cote EP, Lee SF, Hill S, D'Aragon F, Zarychanski R, Rochwerg B, Chasse M, Binnie A, Honarmand K, Lauzier F, Ball I, Al-Hazzani W, Archambault P, Duan E, Khwaja K, Lellouche F, Lysecki P, Marquis F, Naud JF, Shahin J, Shea J, Tsang JLY, Wang HT, Crowther M, Arnold DM, Di Sante E, Marfo G, Kovalova T, Fonguh S, Vincent J, Connolly SJ. Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1872-1881. doi: 10.1001/jama.2023.20820.
PubMed 37824152
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03578419
- Acronym / sponsor ID
- STRATUS / STRATUS
- Conditions
- Blood Loss Anemia
- Keywords
- Anemia, Blood transfusion, Intensive Care Unit, Blood sampling, Stepped wedge, Red blood cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,411 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Period | Active comparator | Device: Standard-Volume Blood Collection TubesStandard-Volume Blood Collection Tubes |
| Intervention Period | Experimental | Device: Small-Volume Blood Collection TubesSmall-Volume Blood Collection Tubes ("soft-draw") |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small-Volume Blood Collection TubesSmall-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes. | Device | Intervention Period |
| Standard-Volume Blood Collection TubesStandard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes. | Device | Control Period |
Primary outcome
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.
3 secondary outcomes
Hemoglobin Concentration
Time frame: 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
ICU and hospital mortality
Time frame: through study completion, an average of 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 37824152Siegal DM, Belley-Cote EP, Lee SF, Hill S, D'Aragon F, Zarychanski R, Rochwerg B, Chasse M, Binnie A, Honarmand K, Lauzier F, Ball I, Al-Hazzani W, Archambault P, Duan E, Khwaja K, Lellouche F, Lysecki P, Marquis F, Naud JF, Shahin J, Shea J, Tsang JLY, Wang HT, Crowther M, Arnold DM, Di Sante E, Marfo G, Kovalova T, Fonguh S, Vincent J, Connolly SJ. Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1872-1881. doi: 10.1001/jama.2023.20820.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Siegal, MD MSc FRCPC principal investigator
Population Health Research Institute; McMaster University
Stuart Connolly, MD study chair
Population Health Research Institute; McMaster University
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small-Volume Blood Collection Tubes and Standard-Volume Blood Collection Tubes in people with Blood Loss Anemia, run by Population Health Research Institute at 24 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC Transfusions (time frame: through study completion, an average of 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.