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.
Patients receiving ECMO
Patients enrolled in the EXCEL Registry - NCT03793257
Treating clinician regards death as imminent and inevitable
Treating clinician determines it is not in the patient's best interests
Contraindication to RBC transfusion (including known patient preference)
Limitations of care put in place either through patient wishes or the treating medical teams.
Sequential
Liberal RBC Transfusion
Other interventionLiberal transfusion trigger group (patient receives RBC transfusion if Hb \<90g/L).
Restrictive RBC Transfusion
Other interventionRestrictive transfusion trigger group (patient receives RBC transfusion if Hb \<70g/L).
Daily Organ Support for patients on ECMO (DOSE-score).
The primary outcome is the Daily Organ Support for patients on ECMO (DOSE-score), a 6-level daily ordinal outcome measured as the worst status of a patient on each day from day 1 through to day 28 inclusive, which reflects survival, organ support and resource utilisation: 1. dead; 2. on ECMO; 3. invasively mechanically ventilated without ECMO; 4. in ICU but not invasively mechanically ventilated nor on ECMO; 5. in hospital; and 6. discharged from the hospital alive.
Development of major haemorrhage at 28 days
Development of major haemorrhage
Development of intracranial haemorrhage at 28 days
Development of intracranial haemorrhage
Mortality at 28 days
Living status.
ECMO-free days at 28 days
Number of days not receiving ECMO
Mortality at 180 days
Platform Trial Tertiary Outcome
Disability at 180 days
Platform Trial Tertiary Outcome - measured by WHODAS 2.0 at 180-days
Functional Status at 180 days
Platform Trial Tertiary Outcome - measured using Lawton-Brody IADL and Barthel ADL
Quality of Life at 180 days
Platform Trial Tertiary Outcome - measured by Eq-5D-5L and EQ-VAS
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Australian and New Zealand Intensive Care Research Centre
Lead sponsor
Monash University
Collaborator
Berry Consultants
Collaborator
Research Path
Collaborator
