NCT03284944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

July 9, 2017

Last Update Submit

September 16, 2020

Conditions

Blood Loss Anemia

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    6 week intervention period

  • Sufficient volume for testing with small-volume tubes

    Defined as \<3% of samples reported as inadequate volume for testing

    6 week intervention period

  • Acceptability of the intervention by end-users

    Acceptability qualitatively evaluated during structured focus group discussions

    6 week intervention period

  • Complete primary data collection

    Defined as at least 95% of patients with complete data collected

    14 weeks

Secondary Outcomes (5)

  • Reduction in blood loss

    12 weeks

  • RBC units transfused

    12 weeks

  • Change in hemoglobin

    12 weeks

  • ICU and hospital length of stay

    12 weeks

  • ICU and hospital mortality

    12 weeks

Study Arms (2)

Control (Before) Period

Use of standard-volume blood collection tubes (6 weeks)

Device: Standard-Volume

Intervention (After) Period

Use of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period)

Device: Small-Volume

Interventions

Small-VolumeDEVICE

Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Intervention (After) Period
Standard-VolumeDEVICE

Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Control (Before) Period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 37505420DERIVED

Study Officials

  • Deborah Siegal, MD

    Population Health Research Institute, McMaster University, Hamilton Health Sciences

    PRINCIPAL INVESTIGATOR

  • Stuart Connolly, MD

    Population Health Research Institute, McMaster University, Hamilton Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2017

First Posted

September 15, 2017

Study Start

November 1, 2017

Primary Completion

February 7, 2018

Study Completion

December 1, 2018

Last Updated

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)