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RECOMMEND Platform Trial

RECRUITINGPhase 3Sponsored by Australian and New Zealand Intensive Care Research Centre
Actively Recruiting
PhasePhase 3
SponsorAustralian and New Zealand Intensive Care Research Centre
Started2026-03-23
Est. completion2028-06
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06526533

Summary

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.

Eligibility

Healthy volunteers accepted
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

Conditions6

ARDS (Acute Respiratory Distress Syndrome)Cardiac Arrest (CA)Critical IllnessExtracorporeal Membrane Oxygenation ComplicationHeart DiseaseIntensive Care Medicine

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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