Small-Volume Tubes to Reduce Anemia and Transfusion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Blood Loss Anemia

Intervention / Treatment
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* Device: Small-Volume Blood Collection Tubes
* Device: Standard-Volume Blood Collection Tubes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| ICU and hospital length of stay | Length of stay in the ICU and hospital | through study completion, an average of 1.5 years | 
| ICU and hospital mortality | Mortality rates in the ICU and hospital | through study completion, an average of 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Blood transfusion, Intensive Care Unit, Blood sampling, Stepped wedge, Red blood cells