RECOMMEND platform testing interventions for adults receiving ECMO

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St. Vincent's Hospital Sydney
  Sydney, New South Wales, Australia Recruiting
• Royal Prince Alfred Hospital
  Camperdown, New South Wales, Australia Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.