Trial of Indication-Based Transfusion of Red Blood Cells in ECMO

Running, not enrolling · Not applicable

Conditions studied: Extracorporeal Membrane Oxygenation, Red Blood Cell Transfusion, Organ Failure, Multiple

In brief

TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support.

Key facts

Study ID

NCT05405426

Run by

Boston Children's Hospital

People needed

228

Starts

2023-04-14

Expected to finish

2026-12-01

Last updated by the study team

2026-07-02

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age < 6 year at ECMO cannulation
• Veno-arterial (VA) mode of ECMO
• First ECMO run during the index hospitalization

You may not qualify if…

• Gestationally-corrected age < 37 weeks at the time of ECMO cannulation
• Veno-venous (VV) mode of ECMO
• Patients initially started on VV-ECMO and then transitioned to VA ECMO > 18 hours after ECMO cannulation
• ECMO used for procedural support (ECMO deployed and decannulated in procedural area with no ICU ECMO care) or ECMO duration expected to be < 24 h
• Limitation of care in place or being discussed
• Congenital bleeding disorders
• Hemoglobinopathies
• Primary Residence outside country of enrollment
• Concurrent participation in a separate interventional trial that has potential to impact neurodevelopment status of patient. (note that observational non-interventional studies do not qualify the patient for exclusion). This includes a patient already enrolled in TITRE
• Lack of access to medical records required for calculation of pre-ECMO pSOFA score due to cannulation for ECMO at a non-trial center.
• Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family)
• Planned transition to ventricular assist device (VAD) within 48 hours of commencing ECMO.
• Clinically documented indication for a Red Blood Cell transfusion threshold that differs from the center-specific transfusion threshold (e.g., oncological treatment that limits donor exposure).

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital — Palo Alto, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Riley Children's Hospital — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• MUSC Shawn Jenkins Children's Hospital — Charleston, South Carolina, United States
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
• Children's Health Dallas University of Texas Southwestern — Dallas, Texas, United States
• Texas Children's Hospital - Baylor College of Medicine — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Inova Children's Hospital — Falls Church, Virginia, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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