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

NCT05405426 · tracked via the Priya Life Science Australia tracker

Sponsor

Boston Children's Hospital

Phase

Not applicable

Started

2023-04-14

Last updated

2026-07-02

Condition(s) studied

Extracorporeal Membrane OxygenationRed Blood Cell TransfusionOrgan Failure, Multiple

Investigational drug(s) / intervention(s)

Red blood cell transfusion

Red blood cell transfusion: The intervention is a strategy for when red blood cell transfusion will be administered (see description of Arms). However, volume of RBC transfused in the two arms is not specified by this study. Red blood cell transfusion strategy for ECMO weaning and decannulation is not specified by this study. Red blood cell transfusion after ECMO decannulation is not specified by this study.

Study summary

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.

Eligibility

Sex

ALL

Min age

0 Days

Max age

6 Years

Healthy volunteers

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).

Primary outcome measure(s)

Baseline-adjusted change in pSOFA (pediatric Sequential Organ Failure Assessment) score — At randomization and at 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
The pSOFA score ranges from 0 (no organ dysfunction) through 24 (severe dysfunction in all 6 organs assessed). If death occurs during ECMO within 30 days, a score of 24 is assigned.
Bayley Infant Scales of Development, 4th edition (Bayley-4) — One year post-randomization (+/- 2 mo)
Scales for Cognitive, Language (Expressive and Receptive), Motor (Gross and Fine), and Social-Emotional. For ages 16 days to 42 months. Composite score range is 40 to 160. Higher scores indicate better performance.
Wechsler Preschool and Primary Scale of Intelligence (WPPSI - IV) — One year post-randomization (+/-2 mo)
Index scores include Verbal Comprehension, Visual Spatial, Working Memory, and Full Scale Intelligence Quotient (IQ). Score range is 40 to 160. Higher scores indicate better performance.

Trial sites (22)

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

Other trials for the same condition

ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05405426 on ClinicalTrials.gov ↗ ← All trials in Australia