The goal of this platform trial is to determine the efficacy, safety and cost-effectiveness of various interventions in patients with acute cardiorespiratory failure requiring extracorporeal membrane oxygenation (ECMO)
The main question the platform trial aims to address is to determine the effect of a range of interventions on survival, organ support and resource utilisation to day 28 for hospitalised patients receiving ECMO.
Researchers will compare various interventions within multiple platform trial domains to see if the interventions have effects on survival, organ support and resource utilisation for the patient cohort.
Participants will be enrolled in accordance with the platform trial's domain structure to answer the research questions.
Who can participate
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.
PLATFORM INCLUSION CRITERIA:
* Patients receiving ECMO
* Patients enrolled in the EXCEL Registry - NCT03793257
PLATFORM EXCLUSION CRITERIA:
* Treating clinician regards death as imminent and inevitable
* Treating clinician determines it is not in the patient's best interests
RBC TRANSFUSION DOMAIN INCLUSION CRITERIA:
• Aged 18 years or older
RBC TRANSFUSION DOMAIN EXCLUSION CRITERIA:
* Contraindication to RBC transfusion (including known patient preference)
* Limitations of care put in place either through patient wishes or the treating medical teams.
* Participant has already received ECMO \>12 hours. The start of ECMO is defined as the time of initiation of extracorporeal blood flow unless ECMO was initiated during a surgical intervention in which case the start of ECMO is defined as the arrival time into the initial ICU (post-surgery)
* The treating physician anticipates that ECMO treatment will cease before the end of tomorrow
* The treating physician deems the study is not in the patient's best interest
* The treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds
* Actively listed for a solid organ transplant and has not yet received one
* Suspected or confirmed to be pregnant
* Previous ECMO treatment during the same hospital admission
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.
1Since this is a Phase 3 trial focused on patients already on ECMO, does my current condition — whether it's ARDS, cardiac arrest, or another critical illness — actually match the type of patients this trial is designed for, and would my care team be able to enroll me while managing everything else that's going on?
2The trial measures something called the DOSE-score, which tracks daily organ support — can you explain what that means in practice for me, and how changes in that score would affect decisions about my ECMO treatment during the study?
3Because ECMO itself carries serious risks like bleeding, clotting, and infection, how does participating in this platform trial change — or not change — the standard safety monitoring and decision-making my team would normally do?
4This is described as a 'platform trial,' which can test multiple treatments at once — can you tell me exactly which intervention or comparison I would be assigned to, and what the realistic alternatives are if I don't join the trial?
5Given how serious and fast-moving conditions like ARDS or cardiac arrest can be, how much time would my family or I realistically have to understand and think through the decision to participate, and who would be advocating specifically for my interests throughout the study?
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
Daily Organ Support for patients on ECMO (DOSE-score).
Timeframe: 28-days.
Trial details
NCT IDNCT06526533
SponsorAustralian and New Zealand Intensive Care Research Centre