Small-Volume Tubes to Reduce Anemia and Transfusion

Blood Loss Anemia Clinical Trial

— STRATUS  

Official title:

Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03578419
• Other study ID #: STRATUS
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: June 30, 2024
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

ICUs will be eligible if they meet the following criteria:

1. Adult ICU

2. At least 14 level 2-3 ICU beds with capacity for invasive mechanical ventilation

3. Use of vacuum tubes for routine blood collection

4. Able to achieve at least 25% estimated reduction in blood volume by switching to small-volume vacuum tubes

5. Electronic administrative and health record data available for data collection

Related Conditions & MeSH terms

• Anemia
• Blood Loss Anemia

Intervention

Device:
• Small-Volume Blood Collection Tubes
Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
• Standard-Volume Blood Collection Tubes
Standard-volume (= 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.

Locations

Country	Name	City	State
Canada	William Osler Health System - Brampton Civic	Brampton	Ontario
Canada	Joseph Brant Hospital	Burlington	Ontario
Canada	William Osler Health System - Etobicoke General	Etobicoke	Ontario
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	Hôtel-Dieu de Lévis	Lévis	Quebec
Canada	London Health Sciences Centre - CCTC	London	Ontario
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	CHUM - AB cardiothoracic	Montreal	Quebec
Canada	CHUM - CD transplants/surgical ICU	Montreal	Quebec
Canada	CHUM - EF neuro ICU	Montreal	Quebec
Canada	Maisonneuve-Rosemont	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Montreal General Hospital	Montréal	Quebec
Canada	CHU de Quebec - Hotel Dieu	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec
Canada	CHU de Quebec - Enfant-Jésus	Québec	Quebec
Canada	St. Catharine's General Hospital	Saint Catherines	Ontario
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Universite de Sherbrooke - Hopital Fleurimont	Sherbrooke	Quebec
Canada	Universite de Sherbrooke - Hôtel-Dieu	Sherbrooke	Quebec
Canada	Ciuss-McQ-Chaur	Trois-Rivières	Quebec
Canada	University of Manitoba - Health Sciences Centre	Winnipeg	Manitoba

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	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.	through study completion, an average of 1.5 years
Secondary	Hemoglobin Concentration	Change in hemoglobin concentration from ICU admission to ICU discharge adjusted for number of RBC transfusions received	through study completion, an average of 1.5 years
Secondary	ICU and hospital length of stay	Length of stay in the ICU and hospital	through study completion, an average of 1.5 years
Secondary	ICU and hospital mortality	Mortality rates in the ICU and hospital	through study completion, an average of 1.5 years