RECOMMEND platform testing interventions for adults receiving ECMO
Generating New Evidence to Reduce Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure (RECOMMEND)
This platform tests whether different treatments, such as liberal versus restrictive red blood cell transfusion strategies, help adults on ECMO survive and need less organ support and hospital resources by day 28.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | Australian and New Zealand Intensive Care Research Centre Academic / other |
| Locations | 3 sites (Camperdown, New South Wales and 2 other locations) |
| Trial ID | NCT06526533 on ClinicalTrials.gov |
What this trial studies
RECOMMEND is an investigator-initiated, multicentre, open-label randomized adaptive platform conducted in Australian ICUs using Bayesian logic to compare multiple interventions for adults receiving ECMO. Participants are enrolled via the national EXCEL registry and allocated within domain structures to receive interventions either simultaneously or sequentially, with primary outcomes of survival, organ support and resource use to day 28. One core domain compares liberal versus restrictive red blood cell transfusion thresholds, and additional domains can be added or stopped based on adaptive analyses. The design aims to efficiently identify effective, safe, and cost-effective strategies for this high-risk, resource-intensive population.
Who should consider this trial
Good fit: Adults (≥18 years) receiving ECMO at a participating Australian ICU who are enrolled in the EXCEL registry and meet the domain-specific inclusion criteria are eligible.
Not a fit: Patients with imminent, unavoidable death, those with contraindications to a domain intervention (for example refusal of blood transfusion), or those expected to cease ECMO within 24 hours are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the platform could identify treatments that increase survival, shorten time on organ support, and reduce ICU costs for people receiving ECMO.
How similar studies have performed: Adaptive platform trials and transfusion-threshold trials in critical care have produced useful results, but an adaptive platform focused specifically on ECMO patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Camperdown, New South Wales and 2 other locations
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Not_yet_recruiting)
- St. Vincent's Hospital Sydney — Sydney, New South Wales, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Curtis Hopkins, B.BioMed, MPH, MHA
- Email: curtis.hopkins@monash.edu
- Phone: +61 3 9903 0343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.