RECRUITING

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

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Conditions

Extracorporeal Membrane OxygenationRed Blood Cell TransfusionOrgan Failure, MultiplepediatricchildrenECMOtransfusionneurodevelopmentTITRE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-14
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05405426

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.

Ages Eligible for Study:0 Days to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Age \< 6 year at ECMO cannulation
  2. 2. Veno-arterial (VA) mode of ECMO
  3. 3. First ECMO run during the index hospitalization
  1. 1. Gestationally-corrected age \< 37 weeks at the time of ECMO cannulation
  2. 2. Veno-venous (VV) mode of ECMO
  3. 3. Patients initially started on VV-ECMO and then transitioned to VA ECMO
  4. 4. ECMO used for procedural support (ECMO deployed and decannulated in procedural area with no ICU ECMO care)
  5. 5. ECMO duration expected to be \< 24 h
  6. 6. Limitation of care in place or being discussed
  7. 7. Congenital bleeding disorders
  8. 8. Hemoglobinopathies
  9. 9. Primary Residence outside country of enrollment
  10. 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. 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. 12. Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family)
  13. 13. Planned transition to ventricular assist device (VAD) within 48 hours of commencing ECMO.

Contacts and Locations

Study Contact

Ravi Thiagarajan, MBBS
CONTACT
617-355-4023
ravi.thiagarajan@cardio.chboston.org
Peta Alexander, MBBS
CONTACT
617-355-1822
peta.alexander@cardio.chboston.org

Principal Investigator

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

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Lucile Packard Children's Hospital
Palo Alto, California, 94304
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Lurie Children's Hospital
Chicago, Illinois, 60611
United States
Riley Children's Hospital
Indianapolis, Indiana, 46202
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
MUSC Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
Children's Health Dallas University of Texas Southwestern
Dallas, Texas, 75235
United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84132
United States
Inova Children's Hospital
Falls Church, Virginia, 22042
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-14
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-04-14
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • pediatric
  • children
  • ECMO
  • transfusion
  • neurodevelopment
  • TITRE

Additional Relevant MeSH Terms

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