Small-Volume Tubes to Reduce Anemia and Transfusion

NCT03578419 | Completed

• 1 other identifier: STRATUS
• Study Type: interventional
• Target: 27,411
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Blood Loss Anemia

Keywords

Anemia; Blood transfusion; Intensive Care Unit; Blood sampling; Stepped wedge; Red blood cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemoglobin Concentration

  through study completion, an average of 1.5 years

• ICU and hospital length of stay

  through study completion, an average of 1.5 years

• ICU and hospital mortality

  through study completion, an average of 1.5 years

Study Arms (2)

Control Period

ACTIVE COMPARATOR

Standard-Volume Blood Collection Tubes

Device: Standard-Volume Blood Collection Tubes

Intervention Period

EXPERIMENTAL

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

Device: Small-Volume Blood Collection Tubes

Interventions

Small-Volume Blood Collection Tubes DEVICE

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

Intervention Period

Standard-Volume Blood Collection Tubes DEVICE

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

Control Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (24)

University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Location

William Osler Health System - Brampton Civic

Brampton, Ontario, Canada

Location

Joseph Brant Hospital

Burlington, Ontario, Canada

Location

William Osler Health System - Etobicoke General

Etobicoke, Ontario, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Centre - CCTC

London, Ontario, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Location

St. Catharine's General Hospital

Saint Catherines, Ontario, Canada

Location

Hôtel-Dieu de Lévis

Lévis, Quebec, Canada

Location

CHUM - AB cardiothoracic

Montreal, Quebec, Canada

Location

CHUM - CD transplants/surgical ICU

Montreal, Quebec, Canada

Location

CHUM - EF neuro ICU

Montreal, Quebec, Canada

Location

Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Montreal General Hospital

Montreal, Quebec, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

CHU de Quebec - Enfant-Jésus

Québec, Quebec, Canada

Location

Universite de Sherbrooke - Hopital Fleurimont

Sherbrooke, Quebec, Canada

Location

Universite de Sherbrooke - Hôtel-Dieu

Sherbrooke, Quebec, Canada

Location

Ciuss-McQ-Chaur

Trois-Rivières, Quebec, Canada

Location

CHU de Quebec - Hotel Dieu

Québec, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Canada

Location

Related Publications (1)

• 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.

  PMID: 37824152 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Deborah Siegal, MD MSc FRCPC

  Population Health Research Institute; McMaster University

  PRINCIPAL INVESTIGATOR

• Stuart Connolly, MD

  Population Health Research Institute; McMaster University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 6, 2018
• Study Start: January 1, 2019
• Primary Completion: January 21, 2021
• Study Completion: June 28, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

CA (24)