Blood Loss AnemiaNCT03284944
Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS)
An observational study of Blood Loss Anemia, run by Population Health Research Institute at 1 site 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 and Standard-Volume
- Type of treatment
- Medical device
- How many people
- 369 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 1 Dec 2018
- Phase
- Observational
- 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
Study population: All adult patients admitted to the participating intensive care unit at the investigative site.
Investigative Site Eligibility:
- Intensive care unit with at least 15 beds with capacity for mechanical ventilation
- Current standard to use standard-draw blood collection tubes
- Availability of hospital administrative data and electronic patient information
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, L8L2X2
About this study
Official title: Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS): A Pilot Study
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
The STRATUS Pilot Study is a prospective observational study (before-after design) to assess the feasibility of implementing a full-scale randomized trial powered for clinical outcomes (RBC transfusion, incidence and severity of anemia). Identification of barriers and facilitators of implementation will enhance the conduct of the full-scale trial and facilitate incorporation of the intervention into routine practice.
- Conditions
- Blood Loss Anemia
- Being tested
- Small-Volume, Standard-Volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small-VolumeDevice
Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
Standard-VolumeDevice
Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
| Study group | Role | What they receive |
|---|---|---|
| Control (Before) Period | Use of standard-volume blood collection tubes (6 weeks) Receives: Device: Standard-Volume | |
| Intervention (After) Period | Use of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period) Receives: Device: Small-Volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful crossover from standard-volume to small-volume tubes
Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period
Measured: 2 week washout period
Adherence to the correct tube size during the intervention period
Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area
Measured: 6 week intervention period
Sufficient volume for testing with small-volume tubes
Defined as <3% of samples reported as inadequate volume for testing
Measured: 6 week intervention period
Acceptability of the intervention by end-users
Acceptability qualitatively evaluated during structured focus group discussions
Measured: 6 week intervention period
Complete primary data collection
Defined as at least 95% of patients with complete data collected
Measured: 14 weeks
Secondary outcomes (5)
Reduction in blood loss
Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes.
Measured: 12 weeks
RBC units transfused
Number of RBC units transfused per patient-day in the ICU.
Measured: 12 weeks
Change in hemoglobin
Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion.
Measured: 12 weeks
ICU and hospital length of stay
ICU and hospital length of stay
Measured: 12 weeks
ICU and hospital mortality
ICU and in-hospital mortality
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start1 Nov 2017
- Primary completion7 Feb 2018
- Study completion1 Dec 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Siegal, MD, Principal investigator, Population Health Research Institute, McMaster University, Hamilton Health SciencesStuart Connolly, MD, Principal investigator, Population Health Research Institute, McMaster University, Hamilton Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284944
- Sponsor's protocol ID
- STRATUS Pilot
- Status last verified
- Sep 2020
- First submitted
- 9 Jul 2017
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegal DM, Belley-Cote EP, Lee SF, Robertson T, Hill S, Benoit P, Meeks B, Owen J, Roglich T, Zotova E, Connolly SJ. Small-volume tubes to reduce anemia and transfusion (STRATUS): a pilot study. Can J Anaesth. 2023 Nov;70(11):1797-1806. doi: 10.1007/s12630-023-02548-6. Epub 2023 Jul 28.
PubMed 37505420
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS): A Pilot Study
- ClinicalTrials.gov ID
- NCT03284944
- Acronym / sponsor ID
- STRATUS Pilot
- Conditions
- Blood Loss Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 15 Sep 2017 (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
The STRATUS Pilot Study is a prospective observational study (before-after design) to assess the feasibility of implementing a full-scale randomized trial powered for clinical outcomes (RBC transfusion, incidence and severity of anemia). Identification of barriers and facilitators of implementation will enhance the conduct of the full-scale trial and facilitate incorporation of the intervention into routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Before) Period | – | Device: Standard-VolumeUse of standard-volume blood collection tubes (6 weeks) |
| Intervention (After) Period | – | Device: Small-VolumeUse of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to the participating intensive care unit at the investigative site.
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-VolumeSmall-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes. | Device | Intervention (After) Period |
| Standard-VolumeStandard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes. | Device | Control (Before) Period |
Primary outcome
Successful crossover from standard-volume to small-volume tubes
Time frame: 2 week washout period
Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period
Adherence to the correct tube size during the intervention period
Time frame: 6 week intervention period
Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area
Sufficient volume for testing with small-volume tubes
Time frame: 6 week intervention period
Defined as <3% of samples reported as inadequate volume for testing
Acceptability of the intervention by end-users
Time frame: 6 week intervention period
Acceptability qualitatively evaluated during structured focus group discussions
Complete primary data collection
Time frame: 14 weeks
Defined as at least 95% of patients with complete data collected
5 secondary outcomes
Reduction in blood loss
Time frame: 12 weeks
RBC units transfused
Time frame: 12 weeks
Change in hemoglobin
Time frame: 12 weeks
ICU and hospital length of stay
Time frame: 12 weeks
ICU and hospital mortality
Time frame: 12 weeks
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 17 Sep 2020.
- Derived from this study: PubMed 37505420Siegal DM, Belley-Cote EP, Lee SF, Robertson T, Hill S, Benoit P, Meeks B, Owen J, Roglich T, Zotova E, Connolly SJ. Small-volume tubes to reduce anemia and transfusion (STRATUS): a pilot study. Can J Anaesth. 2023 Nov;70(11):1797-1806. doi: 10.1007/s12630-023-02548-6. Epub 2023 Jul 28.
- Individual participant dataSharing planned: No
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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 principal investigator
Population Health Research Institute, McMaster University, Hamilton Health Sciences
Stuart Connolly, MD principal investigator
Population Health Research Institute, McMaster University, Hamilton Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss Anemia, run by Population Health Research Institute at 1 site 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 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Successful crossover from standard-volume to small-volume tubes (time frame: 2 week washout period). The study lists 5 primary outcomes in all. 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 NCT03284944, 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 17 Sep 2020.