STRATUS: Small-Volume Tubes to Reduce Anemia and Transfusion

Sponsor

Population Health Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03578419

Collaborator

(none)

10,000

Enrollment

Location

Arms

Anticipated Duration (Months)

208.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss Anemia	Device: Small-Volume Blood Collection Tubes Device: Standard-Volume Blood Collection Tubes	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10000 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 21, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Period Standard-Volume Blood Collection Tubes	Device: Standard-Volume Blood Collection Tubes Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
Experimental: Intervention Period Small-Volume Blood Collection Tubes ("soft-draw")	Device: Small-Volume Blood Collection Tubes Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.

Arm

Intervention/Treatment

Active Comparator: Control Period

Standard-Volume Blood Collection Tubes

Device: Standard-Volume Blood Collection Tubes

Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.

Experimental: Intervention Period

Small-Volume Blood Collection Tubes ("soft-draw")

Device: Small-Volume Blood Collection Tubes

Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.

Outcome Measures

Primary Outcome Measures

RBC Transfusions [through study completion, an average of 1.5 years]
Average number of red blood cell (RBC) units transfused per patient during ICU admission among patients admitted to ICU for 48 hours or longer.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

ICUs will be eligible if they meet the following criteria:

Adult ICU
At least 14 level 2-3 ICU beds with capacity for invasive mechanical ventilation
Use of vacuum tubes for routine blood collection
Able to achieve at least 25% estimated reduction in blood volume by switching to small-volume vacuum tubes
Electronic administrative and health record data available for data collection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L 2X2

Sponsors and Collaborators

Population Health Research Institute

Investigators

Principal Investigator: Deborah Siegal, MD MSc FRCPC, Population Health Research Institute; McMaster University
Study Chair: Stuart Connolly, MD, Population Health Research Institute; McMaster University