Status:
ACTIVE_NOT_RECRUITING
Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
Lead Sponsor:
Boston Children's Hospital
Conditions:
Extracorporeal Membrane Oxygenation
Red Blood Cell Transfusion
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief 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 re...
Detailed Description
Observational studies of children on ECMO have shown an association between large-volume RBC transfusion and mortality. However, the hematocrit (or hemoglobin) level at which optimal tissue oxygen del...
Eligibility Criteria
Inclusion
- Age \< 6 year at ECMO cannulation
- Veno-arterial (VA) mode of ECMO
- First ECMO run during the index hospitalization
Exclusion
- Gestationally-corrected age \< 37 weeks at the time of ECMO cannulation
- Veno-venous (VV) mode of ECMO
- Patients initially started on VV-ECMO and then transitioned to VA ECMO \> 18 hours after 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
- Limitation of care in place or being discussed
- Congenital bleeding disorders
- Hemoglobinopathies
- Primary Residence outside country of enrollment
- 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
- Lack of access to medical records required for calculation of pre-ECMO pSOFA score due to cannulation for ECMO at a non-trial center.
- Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family)
- 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).
Key Trial Info
Start Date :
April 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT05405426
Start Date
April 14 2023
End Date
December 1 2026
Last Update
October 21 2025
Active Locations (22)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304