RECOMMEND Platform Trial
RECOMMEND
Generating New Evidence to Reduce Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure (RECOMMEND)
1 other identifier
interventional
600
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
May 31, 2025
May 1, 2025
2.8 years
July 25, 2024
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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.
28-days.
Secondary Outcomes (5)
Development of major haemorrhage at 28 days
28-days.
Development of intracranial haemorrhage at 28 days
28 days
Mortality at 28 days
28 days
ECMO-free days at 28 days
28 days
Ventilator-free days at 28 days
28 days
Other Outcomes (10)
Mortality at 180 days
180 days
Disability at 180 days
180 days
Functional Status at 180 days
180 days
- +7 more other outcomes
Study Arms (1)
Participant Group/Arm
OTHERRBC 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)
Interventions
Liberal transfusion trigger group (patient receives RBC transfusion if Hb \<90g/L).
Restrictive transfusion trigger group (patient receives RBC transfusion if Hb \<70g/L).
Eligibility Criteria
You may qualify if:
- Patients receiving ECMO
- Patients enrolled in the EXCEL Registry - NCT03793257
You may not qualify if:
- Treating clinician regards death as imminent and inevitable
- Treating clinician determines it is not in the patient's best interests
- Aged 18 years or older
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Australian and New Zealand Intensive Care Research Centrelead
- Monash Universitycollaborator
- Berry Consultantscollaborator
- Research Pathcollaborator
Study Sites (3)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St. Vincent's Hospital Sydney
Sydney, New South Wales, 2010, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carol Hodgson, PhD FACP FAHMS
Monash University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
July 30, 2024
Study Start
September 1, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
May 31, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
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.