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

Recruiting

I'm Interested

Trial ID: NCT05405426

Purpose

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.

Official Title

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

Stanford Investigator(s)

Eligibility

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 or withdrawal of support discussed or in place after ECMO deployment
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
11. Patients cannulated for ECMO at a non-trial center and transferred to a trial site. An exception: those cannulated for ECMO at another non-trial site location that is part of the same healthcare system and subsequently transferred to a trial site will be eligible
12. Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family
13. ECMO deployed as a bridge to ventricular assist device

Intervention(s):

other: Red blood cell transfusion

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathleen Ryan, MD
650-723-7914