Clinical trial NCT03578419: Small-Volume Tubes to Reduce Anemia and Transfusion
Official title: Small-Volume Tubes to Reduce Anemia and Transfusion: A Pragmatic Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss Anemia
Keywords: Anemia
Blood transfusion
Intensive Care Unit
Blood sampling
Stepped wedge
Red blood cells
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 27411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A stepped wedge cluster randomized trial in which ICUs (clusters) switch from a strategy of blood collection using standard-draw tubes (control) to soft-draw tubes (intervention). In this design, the timing at which individual ICUs switch to the intervention is randomly assigned.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: RBC Transfusions
timeFrame: through study completion, an average of 1.5 years
Secondary outcomes:
measure: Hemoglobin Concentration
timeFrame: through study completion, an average of 1.5 years
measure: ICU and hospital length of stay
timeFrame: through study completion, an average of 1.5 years
measure: ICU and hospital mortality
timeFrame: through study completion, an average of 1.5 years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba - Health Sciences Centre
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Brampton
country: Canada
facility: William Osler Health System - Brampton Civic
state: Ontario
city: Burlington
country: Canada
facility: Joseph Brant Hospital
state: Ontario
city: Etobicoke
country: Canada
facility: William Osler Health System - Etobicoke General
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - CCTC
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Saint Catherines
country: Canada
facility: St. Catharine's General Hospital
state: Ontario
city: Lévis
country: Canada
facility: Hôtel-Dieu de Lévis
state: Quebec
city: Montreal
country: Canada
facility: CHUM - AB cardiothoracic
state: Quebec
city: Montreal
country: Canada
facility: CHUM - CD transplants/surgical ICU
state: Quebec
city: Montreal
country: Canada
facility: CHUM - EF neuro ICU
state: Quebec
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montréal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec - Enfant-Jésus
state: Quebec
city: Sherbrooke
country: Canada
facility: Universite de Sherbrooke - Hopital Fleurimont
state: Quebec
city: Sherbrooke
country: Canada
facility: Universite de Sherbrooke - Hôtel-Dieu
state: Quebec
city: Trois-Rivières
country: Canada
facility: Ciuss-McQ-Chaur
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Hotel Dieu
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
affiliation: Population Health Research Institute; McMaster University
name: Deborah Siegal, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute; McMaster University
name: Stuart Connolly, MD
role: STUDY_CHAIR
References: