Trial of Indication-Based Transfusion of Red Blood Cells in ECMO (NCT05405426) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
United States, Australia, Canada228 participantsStarted 2023-04-14
Plain-language 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 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.
Who can participate
Age range
0 Days – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \< 6 year at ECMO cannulation
. Veno-arterial (VA) mode of ECMO
. First ECMO run during the index hospitalization
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline-adjusted change in pSOFA (pediatric Sequential Organ Failure Assessment) score
Timeframe: At randomization and at 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
2
Bayley Infant Scales of Development, 4th edition (Bayley-4)
Timeframe: One year post-randomization (+/- 2 mo)
3
Wechsler Preschool and Primary Scale of Intelligence (WPPSI - IV)