Indication-based red blood cell transfusion for children on ECMO

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

This study is testing if giving blood transfusions to young children on ECMO based on their specific needs, rather than standard blood levels, can help their organs work better and improve their development.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 0 Days to 6 Years
• Sex: All
• Sponsor: Boston Children's Hospital (Academic / other)
• Locations: 22 sites (Phoenix, Arizona and 21 other locations)
• Trial ID: NCT05405426 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether an indication-based strategy for red blood cell (RBC) transfusion can improve organ function and neurodevelopmental outcomes in critically ill children under 6 years of age receiving Extracorporeal Membrane Oxygenation (ECMO). The study will randomly assign participants to receive transfusions based on clinical indications rather than standard hemoglobin or hematocrit thresholds. Conducted at multiple centers, the trial will include a target sample size of 228 patients and will assess outcomes related to organ dysfunction and quality of life one year post-randomization.

Who should consider this trial

Good fit: Ideal candidates are children under 6 years of age who are receiving veno-arterial ECMO support.

Not a fit: Patients with congenital bleeding disorders or those receiving veno-venous ECMO will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better organ function and improved neurodevelopmental outcomes for critically ill children on ECMO.

How similar studies have performed: Previous observational studies have indicated a potential link between large-volume RBC transfusions and increased mortality, suggesting that this approach may be novel and untested in a randomized clinical setting.

Eligibility criteria

Inclusion Criteria:

1. Age \< 6 year at ECMO cannulation
2. Veno-arterial (VA) mode of ECMO
3. First ECMO run during the index hospitalization

Exclusion Criteria:

1. Gestationally-corrected age \< 37 weeks at the time of ECMO cannulation
2. Veno-venous (VV) mode of ECMO
3. Patients initially started on VV-ECMO and then transitioned to VA ECMO \> 18 hours after ECMO cannulation
4. 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
5. Limitation of care in place or being discussed
6. Congenital bleeding disorders
7. Hemoglobinopathies
8. Primary Residence outside country of enrollment
9. 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
10. Lack of access to medical records required for calculation of pre-ECMO pSOFA score due to cannulation for ECMO at a non-trial center.
11. Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family)
12. Planned transition to ventricular assist device (VAD) within 48 hours of commencing ECMO.
13. 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 this trial is running

Phoenix, Arizona and 21 other locations

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

Study contacts

• Principal investigator: Lynn A. Sleeper, ScD — Boston Children's Hospital
• Study coordinator: Ravi Thiagarajan, MBBS

Conditions Extracorporeal Membrane Oxygenation; Red Blood Cell Transfusion; Organ Failure, Multiple; pediatric; children; ECMO; transfusion; neurodevelopment