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

Blood Loss Anemia Clinical Trial

Official title:

Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS): A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284944
• Other study ID #: STRATUS Pilot
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2020
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: December 1, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Blood Loss Anemia

Intervention

Device:
• Small-Volume
Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
• Standard-Volume
Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Sufficient volume for testing with small-volume tubes	Defined as <3% of samples reported as inadequate volume for testing	6 week intervention period
Primary	Acceptability of the intervention by end-users	Acceptability qualitatively evaluated during structured focus group discussions	6 week intervention period
Primary	Complete primary data collection	Defined as at least 95% of patients with complete data collected	14 weeks
Secondary	Reduction in blood loss	Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes.	12 weeks
Secondary	RBC units transfused	Number of RBC units transfused per patient-day in the ICU.	12 weeks
Secondary	Change in hemoglobin	Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion.	12 weeks
Secondary	ICU and hospital length of stay	ICU and hospital length of stay	12 weeks
Secondary	ICU and hospital mortality	ICU and in-hospital mortality	12 weeks