Actively Recruiting
Red Blood Cell Transfusion in ECMO - A Feasibility Trial
Led by Australian and New Zealand Intensive Care Research Centre · Updated on 2025-05-31
120
Participants Needed
2
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intense treatment used to support critically ill patients who have suffered severe cardiac arrest, cardiac failure or respiratory failure (including severe cases of COVID-19). ECMO acts as a mechanical circulatory support temporarily replacing the function of the heart or lungs by oxygenating blood and removing carbon dioxide, allowing time for these organs to recover. Many critically ill patients, including those on ECMO, have an increased risk of bleeding and reduced production/increased destruction of red blood cells (RBCs). This can lead to anaemia (haemoglobin levels \<120 g/l), a condition where the body lacks enough healthy RBCs to carry enough oxygen to the body's tissues. Therefore, patients on ECMO frequently require RBC transfusion, with clinicians having to decide if administering an RBC transfusion (with its associated risks) is higher than tolerating complications of anaemia. ROSETTA is a feasibility study that aims to determine the safety and feasibility of randomizing patients on ECMO to a restrictive RBC transfusion strategy (maintain Hb concentration above 70g/L) or to a more liberal transfusion strategy (maintain Hb concentration above 90g/L). Feasibility is defined as the ability to achieve a mean separation of at least 10g/L between the average lowest daily haemoglobin values in the two study groups.
CONDITIONS
Official Title
Red Blood Cell Transfusion in ECMO - A Feasibility Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients receiving ECMO
- Age 18 years or older
You will not qualify if you...
- Contraindication to red blood cell transfusion (including known patient preference)
- Limitations of care set by patient wishes or medical team
- ECMO treatment longer than 12 hours prior to enrollment
- Treating physician expects ECMO will stop before the end of the next day
- Treating physician believes participation is not in patient's best interest
- Treating physician concerned patient cannot tolerate transfusion thresholds
- Patients actively listed for solid organ transplant
- Suspected or confirmed pregnancy
- Previous ECMO treatment during the same hospital stay
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
St Vincent's Health Sydney
Sydney, New South Wales, Australia, 2010
Actively Recruiting
Research Team
C
Curtis Hopkins, B.BioMed, MPH, MHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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