Extracorporeal Membrane Oxygenation ComplicationPhase 3RECOMMENDNCT06526533
RECOMMEND Platform Trial
A Phase 3 study testing Liberal RBC Transfusion and Restrictive RBC Transfusion in people with Extracorporeal Membrane Oxygenation Complication and ARDS (Acute Respiratory Distress Syndrome), run by Australian and New Zealand Intensive Care Research Centre at 3 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, ARDS (Acute Respiratory Distress Syndrome), Intensive Care Medicine
- What is being tested?
- Liberal RBC Transfusion and Restrictive RBC Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesAustralia
- Study dates
- 23 Mar 2026to Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Not yet recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Heidi Buhr, heidi.buhr@health.nsw.gov.au
- Not yet recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Aidan Burrell, MD, Aidanburrell@gmail.com
- Recruiting
St. Vincent's Hospital Sydney
Sydney, New South Wales, 2010
Hergen Buscher, MBBS, hergen.buscher@svhs.org.au
About this study
Official title: Generating New Evidence to Reduce Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure (RECOMMEND)
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.
Read more
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.
Read the detailed description
The RECOMMEND Platform trial is an investigator initiated, multicentre, open labelled, randomised controlled Platform Trial that will utilise Bayesian adaptive logic to investigate the efficacy and safety of multiple study interventions simultaneously or sequentially in cohorts of adult patients who are receiving ECMO from ICUs participating in the national ECMO registry (EXCEL) in Australian hospitals (EXCEL Registry NCT03793257).
In this platform trial, various interventions will be investigated for their potential to improve outcomes for patients undergoing ECMO.
Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intensive treatment used to support critically ill patients suffering from severe cardiac arrest, cardiac failure or respiratory failure. ECMO provides mechanical circulatory support, temporarily replacing the function of the heart and/or lungs, allowing time for these organs to recover.
Globally, the use of ECMO has increased rapidly over the past decade. It is both invasive and expensive, with the average cost for a single admission in Australia exceeding more than $180,000 and a total annual cost of > $75 million. Despite its high cost, ECMO is associated with a high mortality rate, and many survivors have compromised functional recovery for months or years after discharge from hospital, further adding to the long-terms costs of care.
The main complications reported in the national ECMO registry from 2019-2022 include bleeding (51.4%), renal failure and fluid overload (78.4%), and death and ongoing disability (66%). These were confirmed as research priorities by consumers and end-users. While the use of ECMO increases swiftly, the evidence base to support the growing patient numbers receiving this care has not grown at the same rate, resulting in important evidence gaps.
The RECOMMEND Platform Trial will address these evidence gaps in ECMO services in Australia. A platform trial is a type of study design that evaluates multiple treatment interventions for a single condition or device simultaneously within a single, overarching framework. This framework operates similarly to a standard operating procedure for study logistics, ethics management, funding, staffing, and statistical and data collection methods. Having an approved process (platform) for the 'Platform Trial' to operate saves time and money and increases speed of clinical trial onboarding to outcome resolution for researchers, hospital staff, ethics committees, and stakeholders. With this platform in place, future studies of similar ECMO outcomes can be onboarded more efficiently, as described above, and it creates a more powerful pool of data for impactful patient-centred research.
Over the lifetime of RECOMMEND, it is anticipated that new interventions will be added as new domains. The creation of new domains will be considered according to priorities set by relevant working groups, based on existing or new clinical need and there being sufficient statistical power available within RECOMMEND.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, ARDS (Acute Respiratory Distress Syndrome), Intensive Care Medicine, Cardiac Arrest (CA), Critical Illness
- Being tested
- Liberal RBC Transfusion, Restrictive RBC Transfusion
- Keywords
- ECMO, ICU, Platform Trial, Australia, Cardiac, Respiratory, VA, VV, eCPR, Adaptive
- Medical subject headings
- Acute Lung Injury, Heart Arrest, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal RBC TransfusionOther
Liberal transfusion trigger group (patient receives RBC transfusion if Hb <90g/L).
Restrictive RBC TransfusionOther
Restrictive transfusion trigger group (patient receives RBC transfusion if Hb <70g/L).
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm | Other | RBC Transfusion Domain:
Patients on ECMO in ICU enrolled in the RBC Transfusion Domain of RECOMMEND. Patients receive one of two RBC transfusion strategies (restrictive or liberal) Receives: Other: Liberal RBC Transfusion; Other: Restrictive RBC Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- dead;
- on ECMO;
- invasively mechanically ventilated without ECMO;
- in ICU but not invasively mechanically ventilated nor on ECMO;
- in hospital; and
- discharged from the hospital alive.
Measured: 28-days.
Secondary outcomes (5)
Development of major haemorrhage at 28 days
Development of major haemorrhage
Measured: 28-days.
Development of intracranial haemorrhage at 28 days
Development of intracranial haemorrhage
Measured: 28 days
Mortality at 28 days
Living status.
Measured: 28 days
ECMO-free days at 28 days
Number of days not receiving ECMO
Measured: 28 days
Ventilator-free days at 28 days
Number of days not receiving ventilation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start23 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Berry Consultants, Research Path
- Responsible party
- Sponsor
- Investigators
- Carol Hodgson, PhD FACP FAHMS, Study chair, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526533
- Sponsor's protocol ID
- ANZIC-RC/CH006
- Acronym
- RECOMMEND
- Status last verified
- May 2026
- First submitted
- 25 Jul 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD is created as individual data are not shared. However, aggregated data presented in manuscripts and publications or similar works, will be accessible upon patient request or own investigation.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating New Evidence to Reduce Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure (RECOMMEND)
- ClinicalTrials.gov ID
- NCT06526533
- Acronym / sponsor ID
- RECOMMEND / ANZIC-RC/CH006
- Conditions
- Extracorporeal Membrane Oxygenation Complication, ARDS (Acute Respiratory Distress Syndrome), Intensive Care Medicine, Cardiac Arrest (CA), Critical Illness
- Keywords
- ECMO, ICU, Platform Trial, Australia, Cardiac, Respiratory, VA, VV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Monash University, Berry Consultants, Research Path
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The RECOMMEND Platform trial is an investigator initiated, multicentre, open labelled, randomised controlled Platform Trial that will utilise Bayesian adaptive logic to investigate the efficacy and safety of multiple study interventions simultaneously or sequentially in cohorts of adult patients who are receiving ECMO from ICUs participating in the national ECMO registry (EXCEL) in Australian hospitals (EXCEL Registry NCT03793257).
In this platform trial, various interventions will be investigated for their potential to improve outcomes for patients undergoing ECMO.
Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intensive treatment used to support critically ill patients suffering from severe cardiac arrest, cardiac failure or respiratory failure. ECMO provides mechanical circulatory support, temporarily replacing the function of the heart and/or lungs, allowing time for these organs to recover.
Globally, the use of ECMO has increased rapidly over the past decade. It is both invasive and expensive, with the average cost for a single admission in Australia exceeding more than $180,000 and a total annual cost of > $75 million. Despite its high cost, ECMO is associated with a high mortality rate, and many survivors have compromised functional recovery for months or years after discharge from hospital, further adding to the long-terms costs of care.
The main complications reported in the national ECMO registry from 2019-2022 include bleeding (51.4%), renal failure and fluid overload (78.4%), and death and ongoing disability (66%). These were confirmed as research priorities by consumers and end-users. While the use of ECMO increases swiftly, the evidence base to support the growing patient numbers receiving this care has not grown at the same rate, resulting in important evidence gaps.
The RECOMMEND Platform Trial will address these evidence gaps in ECMO services in Australia. A platform trial is a type of study design that evaluates multiple treatment interventions for a single condition or device simultaneously within a single, overarching framework. This framework operates similarly to a standard operating procedure for study logistics, ethics management, funding, staffing, and statistical and data collection methods. Having an approved process (platform) for the 'Platform Trial' to operate saves time and money and increases speed of clinical trial onboarding to outcome resolution for researchers, hospital staff, ethics committees, and stakeholders. With this platform in place, future studies of similar ECMO outcomes can be onboarded more efficiently, as described above, and it creates a more powerful pool of data for impactful patient-centred research.
Over the lifetime of RECOMMEND, it is anticipated that new interventions will be added as new domains. The creation of new domains will be considered according to priorities set by relevant working groups, based on existing or new clinical need and there being sufficient statistical power available within RECOMMEND.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm | Other | Other: Liberal RBC Transfusion, Other: Restrictive RBC TransfusionRBC Transfusion Domain: Patients on ECMO in ICU enrolled in the RBC Transfusion Domain of RECOMMEND. Patients receive one of two RBC transfusion strategies (restrictive or liberal) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberal RBC TransfusionLiberal transfusion trigger group (patient receives RBC transfusion if Hb <90g/L). | Other | Participant Group/Arm |
| Restrictive RBC TransfusionRestrictive transfusion trigger group (patient receives RBC transfusion if Hb <70g/L). | Other | Participant Group/Arm |
Primary outcome
Daily Organ Support for patients on ECMO (DOSE-score).
Time frame: 28-days.
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.
5 secondary outcomes
Development of major haemorrhage at 28 days
Time frame: 28-days.
Development of intracranial haemorrhage at 28 days
Time frame: 28 days
Mortality at 28 days
Time frame: 28 days
ECMO-free days at 28 days
Time frame: 28 days
Ventilator-free days at 28 days
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. No IPD is created as individual data are not shared. However, aggregated data presented in manuscripts and publications or similar works, will be accessible upon patient request or own investigation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carol Hodgson, PhD FACP FAHMS study chair
Monash University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liberal RBC Transfusion and Restrictive RBC Transfusion in people with Extracorporeal Membrane Oxygenation Complication and ARDS (Acute Respiratory Distress Syndrome), run by Australian and New Zealand Intensive Care Research Centre at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Curtis Hopkins, B.BioMed, MPH, MHA (+61 3 9903 0343, curtis.hopkins@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Organ Support for patients on ECMO (DOSE-score). (time frame: 28-days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.