RECOMMEND Platform Trial
Generating new evidence to REduce major COMplications to iMprove the safety and efficacy of Extracorporeal membrane oxygenatioN (ECMO) in severe carDiac and respiratory failure Platform Trial
A registry-embedded, randomised, platform trial comparing interventions in various domains for patients receiving ECMO.
Aim
To evaluate, in patients with acute cardiorespiratory failure requiring ECMO, the efficacy, safety, and cost-effectiveness of multiple interventions across trial domains. The primary outcome is survival, organ support, and resource use to day 28 following ECMO cannulation. Secondary outcomes include major complications (haemorrhage, thrombosis), ventilator and ECMO-free days, and mortality.
Rationale
ICU patients on ECMO are critically ill with high risks of death and complications. Current practice varies widely and is guided by limited evidence. The RECOMMEND Platform Trial addresses this gap by providing a flexible framework to test multiple interventions in real time.
The RECOMMEND Platform Trial is embedded in the bi-national ECMO EXCEL Registry. The trial uses registry infrastructure to maximise efficiency and speed translation into practice. The RECOMMEND Platform Trial is patient-centred, informed by patient preferences, and incorporates consumer input.
Bayesian methods and adaptive design allow the trial to respond to emerging data, continuing or stopping interventions based on pre-specified statistical criteria. This approach improves both safety and efficiency while supporting continuous learning in healthcare.
Study Progress
The RECOMMEND Platform Trial is in start-up phase and has not yet begun recruitment. Preparations include protocol finalisation, ethics and governance approvals, and site initiation. As an adaptive platform trial, RECOMMEND will test multiple interventions with no fixed sample size. Recruitment will continue while active domains are open, with new domains added as new clinical questions arise.
Red Blood Cell Transfusion Domain
The first domain will compare two red blood cell (RBC) transfusion strategies in ECMO patients:
- Restrictive: transfuse RBC if haemoglobin <70 g/L
- Liberal: transfuse RBC if haemoglobin <90 g/L
The intervention will continue for up to 28 days of ECMO treatment.
Restrictive transfusion has shown benefit in general ICU patients, but ECMO patients often need more transfusions, face higher bleeding risk, and have lower oxygen delivery. Anaemia is common in the ECMO cohort, making transfusion strategy critical to outcomes, resource use, and costs.
This domain will test whether a lower or higher threshold improves survival, reduces organ support, and aids recovery. The primary outcome is the RECOMMEND Platform Trial DOSE score.
Findings may inform future guidelines, improve safety, and reduce unnecessary transfusions in this high-risk group.
Trial Registration
ClinicalTrials.gov ID: NCT06526533
Funding
Funded by the Medical Research Future Fund (MRF2023109).