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

Extracorporeal Membrane Oxygenation | Organ Failure, Multiple | Red Blood Cell Transfusion

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    0 to 6

Participation 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
4. ECMO used for procedural support (ECMO deployed and decannulated in procedural area with no ICU ECMO care)
5. ECMO duration expected to be \< 24 h
6. Limitation of care in place or being discussed
7. Congenital bleeding disorders
8. Hemoglobinopathies
9. Primary Residence outside country of enrollment
10. 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)
11. Lack of access to medical records required for calculation of pre-ECMO pSOFA score due to cannulation for ECMO at a non-trial center.
12. Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family)
13. Planned transition to ventricular assist device (VAD) within 48 hours of commencing ECMO.

Study Location

The Hospital for Sick Children
The Hospital for Sick Children
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Anne-Marie Guergerian, MD

[email protected]
416-816-7654
Study Sponsored By
Boston Children's Hospital
Participants Required
More Information
Study ID: NCT05405426