RECOMMEND Platform Trial
NCT Number: NCT06526533
Acronym: RECOMMEND
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Extracorporeal Membrane Oxygenation Complication
Interventions: OTHER: Liberal Transfusion|OTHER: Restrictive Transfusion
Sponsor: Australian and New Zealand Intensive Care Research Centre
Collaborators: Monash University|The Alfred
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2028-11-30
Locations: 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

Summary:
Patients in the intensive care unit (ICU) undergoing extracorporeal membrane oxygenation (ECMO) require close monitoring and interventions to support their recovery. The RECOMMEND Platform Trial aims to develop clear, high-quality evidence for ECMO care, to better inform clinicians in this rapidly evolving field.

The RECOMMEND Platform Trial will provide a 'platform' for funding, logistics, and training protocols. This approach enhances efficiency, allowing research to begin, and complete more efficiently. The platform maintains rigorous standards and provides a safe, cost-effective, and time-efficient method for generating knowledge about ECMO care.

Overall, platform clinical trials offer a dynamic and innovative approach that enables the simultaneous evaluation of multiple treatments and the rapid translation of scientific discoveries into improved patient care. The RECOMMEND Platform Trial has been informed by patient preferences and values and will evaluate the effectiveness and safety of various standards of care. This approach supports continuous learning and real-time clinical decision-making to improve patient outcomes.

Primary Outcome Measures: 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 Outcome Measures: ECMO-related bleeding and thrombotic complications at 28-days., Development of major ECMO-related bleeding and thrombotic complications (e.g. stroke, major haemorrhage, amputation)., 28-days.|Mortality at 28-days., Living status., 28-days.|ECMO-free days at 28-days., Number of days not receiving ECMO., 28-days.|Ventilator-free days at 28-days., Number of days not receiving ventilation., 28-days.
Other Outcome Measures: Mortality 180-days, Living status at 180-days., 180-days.|Mortality 180-days, Disability measured by phone call administration of (WHODAS 2.0) at 180-days., 180-days.|Quality of Life 180-days, Quality of Life measured by phone call administration of (Eq-5D-5L and EQ-VAS) at 180-days., 180-days.|Length of stay., ICU and hospital length of stay (separated for survivors and non-survivors)., 180-days.