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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-12-01

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.

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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.

Conditions

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Blood Loss Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control (Before) Period

Use of standard-volume blood collection tubes (6 weeks)

Standard-Volume

Intervention Type DEVICE

Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Intervention (After) Period

Use of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period)

Small-Volume

Intervention Type DEVICE

Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Interventions

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Small-Volume

Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Intervention Type DEVICE

Standard-Volume

Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No