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

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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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.

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

Conditions
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Blood Loss Anemia

Intervention / Treatment
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* Device: Small-Volume
* Device: Standard-Volume


Participation Criteria
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Eligibility Criteria
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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

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control (Before) Period<br>Use of standard-volume blood collection tubes (6 weeks) | Device: Standard-Volume<br>* Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.<br>|
| Intervention (After) Period<br>Use of small-volume (soft-draw) blood collection tubes (6 weeks following 2-week washout period) | Device: Small-Volume<br>* Small-volume (2 - 3 mL soft-draw Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Sufficient volume for testing with small-volume tubes | Defined as <3% of samples reported as inadequate volume for testing | 6 week intervention period | 
| Acceptability of the intervention by end-users | Acceptability qualitatively evaluated during structured focus group discussions | 6 week intervention period | 
| Complete primary data collection | Defined as at least 95% of patients with complete data collected | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in blood loss | Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes. | 12 weeks | 
| RBC units transfused | Number of RBC units transfused per patient-day in the ICU. | 12 weeks | 
| Change in hemoglobin | Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion. | 12 weeks | 
| ICU and hospital length of stay | ICU and hospital length of stay | 12 weeks | 
| ICU and hospital mortality | ICU and in-hospital mortality | 12 weeks |