Trial of Indication Based Transfusion of Red Blood Cells in ECMO (TITRE)

This clinical trial is for children on ExtraCorporeal Membrane Oxygenation (ECMO), a machine used to support the heart and lungs. This study evaluates the method in which ECMO patients are treated with Red Blood Cell (RBC) transfusions. Most ECMO centers provide RBC transfusions to maintain a certain hemoglobin (Hb) or hematocrit level for children on ECMO. However, the Hb/HCT level at which oxygen delivery is best is not known. This study evaluates RBC transfusion practice to improve treatment and outcomes for children requiring ECMO.

Inova Fairfax Medical Campus:
3300 Gallows Road
Falls Church, VA 22042

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

• Gestationally-corrected age < 37 weeks at the time of 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
• Congenital bleeding disorders
• Hemoglobinopathies
• Concurrent participation in a separate interventional trial that has the potential to impact neurodevelopmental status of the patient (note that observational noninterventional studies do not qualify the patient for exclusion). This includes a patient who was already enrolled in TITRE.
• 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).