Status:
NOT_YET_RECRUITING
RECOMMEND Platform Trial
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsors:
Monash University
Berry Consultants
Conditions:
Extracorporeal Membrane Oxygenation Complication
ARDS (Acute Respiratory Distress Syndrome)
Eligibility:
All Genders
Phase:
PHASE3
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 ...
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 sa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06526533
Start Date
September 1 2025
End Date
June 1 2029
Last Update
May 31 2025
Active Locations (3)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
St. Vincent's Hospital Sydney
Sydney, New South Wales, Australia, 2010
3
The Alfred Hospital
Melbourne, Victoria, Australia, 3004