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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Extracorporeal Membrane Oxygenation
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Palo Alto

Lucile Packard Children's Hospital, Palo Alto, California, United States, 94304

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30322

Chicago

Lurie Children's Hospital, Chicago, Illinois, United States, 60611

Indianapolis

Riley Children's Hospital, Indianapolis, Indiana, United States, 46202

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Ann Arbor

University of Michigan Medical Center, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

0 Days to 6 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Lynn A. Sleeper, ScD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2025-12