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

Launched by BOSTON CHILDREN'S HOSPITAL · Jun 1, 2022

Keywords

ClinConnect Summary

The TITRE trial is studying how to best manage red blood cell transfusions in critically ill children who are on a special life-support system called Extracorporeal Membrane Oxygenation (ECMO). The goal is to see if giving transfusions based on specific medical needs, like bleeding or low oxygen levels, can lead to better outcomes than simply following standard blood count levels. This research aims to reduce problems with organ function and improve brain development in these young patients.

To be part of this study, children must be under 6 years old and receiving their first ECMO treatment during their hospital stay. However, some children may not qualify, such as those who are very premature or have certain bleeding disorders. Participants will receive care according to the study's guidelines, which may involve different approaches to blood transfusions. It’s important for families to know that this trial is currently recruiting participants, and they can discuss any questions with their healthcare team to understand more about how it may help their child.

Gender

ALL

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).