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

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss Anemia
• Intervention / Treatment: Device: Standard-Volume; Device: Small-Volume

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 Type: Observational
• Enrollment (Actual): 369

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton Health Sciences - Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted to the participating intensive care unit at the investigative site.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control (Before) Period; Use of standard-volume blood collection tubes (6 weeks)	Device: Standard-Volume; Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
Intervention (After) Period; Use of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period)	Device: Small-Volume; Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in blood loss	Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes.	12 weeks
RBC units transfused	Number of RBC units transfused per patient-day in the ICU.	12 weeks
Change in hemoglobin	Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion.	12 weeks
ICU and hospital length of stay	ICU and hospital length of stay	12 weeks
ICU and hospital mortality	ICU and in-hospital mortality	12 weeks

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): February 7, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: STRATUS Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No