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

Population Health Research Institute (PHRI) logo

Population Health Research Institute (PHRI)

Status

Completed

Conditions

Blood Loss Anemia

Treatments

Device: Standard-Volume Blood Collection Tubes
Device: Small-Volume Blood Collection Tubes

Study type

Interventional

Funder types

Other

Identifiers

NCT03578419
STRATUS

Details and patient eligibility

About

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.

Full 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.

Enrollment

27,411 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

27,411 participants in 2 patient groups

Control Period
Active Comparator group
Description:
Standard-Volume Blood Collection Tubes
Treatment:
Device: Standard-Volume Blood Collection Tubes
Intervention Period
Experimental group
Description:
Small-Volume Blood Collection Tubes ("soft-draw")
Treatment:
Device: Small-Volume Blood Collection Tubes

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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