TITRE is a multicenter trial being conducted in the United States and Canada. The goal of TITRE is to determine whether restricting blood transfusion results in less organ impairment and improves long term outcomes for children who receive ECMO support.
About ECMO & Blood Transfusion
Extracorporeal Membrane Oxygenation (ECMO) is used for heart and lung support. When children are supported on ECMO, they receive a lot of blood transfusions. These are to manage bleeding, and to provide hemoglobin, which is important for carrying oxygen to tissues. Experts believe there may be benefit to using blood transfusions only when there are signs that there is not enough oxygen being delivered to tissues, rather than to target a pre-defined hemoglobin level. In this study, these two different strategies for decision-making around blood transfusion will be studied to see if either strategy is better to prevent organ dysfunction and improve later functional and development outcomes.
Currently, the optimal strategy for blood transfusion in ECMO patients is unknown.
Why TITRE?
Extracorporeal membrane oxygenation (ECMO) can provide life-saving mechanical cardiac and respiratory support to critically ill children, but only about half of children supported with ECMO survive to go home after ECMO. Adverse events are common and long-term function including quality of life may be compromised in many ECMO survivors. TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial being conducted to determine whether there is a better way to care for children receiving this invasive support.
What Will We Learn from TITRE?
The goal of TITRE is to determine whether a different decision-making strategy for blood transfusion can reduce organ dysfunction, and improve later neurodevelopment in critically ill children receiving ECMO support.
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ELIGIBILITY
Can My Child Participate?
Only centers approved by the funding organization can enroll children in the TITRE trial. If your child is: younger than 6 years old; being considered for ECMO or is on ECMO; and is being cared for by one of the institutions below, please discuss with your provider to see if your child may be eligible for the TITRE trial.
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Contact information for each participating institution can be found at clinicaltrials.org. Please contact your local team with questions.
FREQUENTLY ASKED QUESTIONS
What will happen in this research study?
The study lasts 12 months. As part of the study, participants will be randomly assigned to receive blood transfusions according to usual care at the center, or according to the study protocol. We will gather information from participants’ medical records and reach out to participants every 2-3 months after hospital discharge to see how participants’ are doing. Participants will have one additional clinical visit at 12 months after ECMO for neurodevelopmental measurement.
Is there any cost to participate?
Tests that are done for research that are not part of regular care will be provided free of charge. Participants and families will be compensated for time and effort.
Will my privacy be protected?
We take confidentiality very seriously, and will ensure that your right to privacy is protected, and participation in this research study will remain confidential. No names or other identifying information will be used in any published report of information from this study.
Is it possible to leave the study early?
Yes. It is up to the child's family to decide to be in the study. Once in, you may leave the study at any time. Being in the study, or choosing to leave the study, will not affect other medical care at any time.
How long will I be in the study?
Participants are followed for 12 months after enrollment.
Will the results of the study be shared?
We plan to publish what we find out from the study, so we can share this important information with families, researchers, and health care providers. Publications will be announced on this website, and will be communicated through study sites.
Publications
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Publications will be announced here. Please check back soon!
STUDY TEAM
TITRE Trial Leadership
Clinical Coordinating Center
Ravi Thiagarajan, MBBS, MPH
Trial Co-Chair
Jane Newburger, MD, MPH
Neurodevelopment
Co-Investigator
Peta Alexander, MBBS
Trial Co-Chair
Daniel Kelly, MD, MHQS
Transfusion Medicine/Co-Investigator
Data & Statistical Coordinating Center
Lynn Sleeper, ScD
Grant PI & DCC PI
Anjali Sadhwani, PhD
Neurodevelopment Core/
Co-Investigator
David Bellinger, PhD
Director, Neurodevelopment Core
Melania Bembea, MD, PhD
Medical Monitor
(Johns Hopkins University)
Executive Committee
Heidi Dalton, MD
Inova Children’s Hospital
Marie Steiner, MD, MS
University of Minnesota
Philip Spinella, MD
University of Pittsburgh
Jennifer Muszynski, MD, MPH
Nationwide Children’s Hospital
Christopher Almond, MD, MPH
Lucile Packard Children’s Hospital
Adjudication Committee
Joanne Starr, MD
Children’s Hospital of Orange County
Marianne Nellis, MD, MS
Weill Cornell Medical College
Stacey Valentine, MD, MPH
Univ. of Massachusetts Chan Medical School
Site Principal Investigators
Erin Bressler, MD
Ann & Robert H. Lurie Children's Hospital of Chicago
Matthew Malone, MD
Arkansas Children's Hospital
Sally Vitali, MD
Boston Children's Hospital
Asavari Kamerkar, DO
Children's Hospital Los Angeles
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Sirine Baltagi, MD
Children's Health Dallas
John Kim, MD
Children's Hospital Colorado
Heather Viamonte, MD, MPH
Children's Healthcare of Atlanta
Mina Hafzalah, MD
Children's Hospital of Michigan
Benjamin Koyzak, MD
Children's Hospital of Philadelphia
Andrew Misfeldt, MD
Cincinnati Children's Hospital Medical Center
Kate Ryan, MD
Lucile Packard Children's Hospital
Andrew Smith, MD
Monroe Carell Jr. Children's Hospital at Vanderbilt
Renee Potera, MD
Phoenix Children's Hospital
Matthew Friedman, MD, MS
Riley Hospital for Children
University of Indiana
John McGuire, MD
Seattle Children's Hospital
Marc Anders, MD
Texas Children's Hospital
Baylor College of Medicine
Anne-Marie Guerguerian, MD, PhD
The Hospital for Sick Children
Elise Zivick, MD
MUSC Shawn Jenkins Children's Hospital
Ryan Barbaro, MD, MSc
University of Michigan, Ann Arbor
David Bailly, DO
University of Utah
Primary Children's Hospital
Marino Festa, MD, MBBS
Children’s Hospital at Westmead, Sydney
