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Small-Volume Tubes to Reduce Anemia and Transfusion

NCT ID: NCT03578419

Last Updated: 2024-07-01

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

Clinical Phase

NA

Total Enrollment

27411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-06-28

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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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.

Conditions

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Blood Loss Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Period

Standard-Volume Blood Collection Tubes

Group Type ACTIVE_COMPARATOR

Standard-Volume Blood Collection Tubes

Intervention Type DEVICE

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

Intervention Period

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

Group Type EXPERIMENTAL

Small-Volume Blood Collection Tubes

Intervention Type DEVICE

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

Interventions

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Small-Volume Blood Collection Tubes

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

Intervention Type DEVICE

Standard-Volume Blood Collection Tubes

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Siegal, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute; McMaster University

Stuart Connolly, MD

Role: STUDY_CHAIR

Population Health Research Institute; McMaster University

Locations

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University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

William Osler Health System - Brampton Civic

Brampton, Ontario, Canada

Site Status

Joseph Brant Hospital

Burlington, Ontario, Canada

Site Status

William Osler Health System - Etobicoke General

Etobicoke, Ontario, Canada

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

St. Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

London Health Sciences Centre - CCTC

London, Ontario, Canada

Site Status

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Site Status

St. Catharine's General Hospital

Saint Catherines, Ontario, Canada

Site Status

Hôtel-Dieu de Lévis

Lévis, Quebec, Canada

Site Status

CHUM - AB cardiothoracic

Montreal, Quebec, Canada

Site Status

CHUM - CD transplants/surgical ICU

Montreal, Quebec, Canada

Site Status

CHUM - EF neuro ICU

Montreal, Quebec, Canada

Site Status

Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

CHU de Quebec - Enfant-Jésus

Québec, Quebec, Canada

Site Status

Universite de Sherbrooke - Hopital Fleurimont

Sherbrooke, Quebec, Canada

Site Status

Universite de Sherbrooke - Hôtel-Dieu

Sherbrooke, Quebec, Canada

Site Status

Ciuss-McQ-Chaur

Trois-Rivières, Quebec, Canada

Site Status

CHU de Quebec - Hotel Dieu

Québec, , Canada

Site Status

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, , Canada

Site Status

Countries

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Canada

References

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Siegal DM, Belley-Cote EP, Lee SF, Hill S, D'Aragon F, Zarychanski R, Rochwerg B, Chasse M, Binnie A, Honarmand K, Lauzier F, Ball I, Al-Hazzani W, Archambault P, Duan E, Khwaja K, Lellouche F, Lysecki P, Marquis F, Naud JF, Shahin J, Shea J, Tsang JLY, Wang HT, Crowther M, Arnold DM, Di Sante E, Marfo G, Kovalova T, Fonguh S, Vincent J, Connolly SJ. Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1872-1881. doi: 10.1001/jama.2023.20820.

Reference Type DERIVED
PMID: 37824152 (View on PubMed)

Other Identifiers

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STRATUS

Identifier Type: -

Identifier Source: org_study_id

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