NCT05814094 Red Blood Cell Transfusion in ECMO - A Feasibility Trial
| NCT ID | NCT05814094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Australian and New Zealand Intensive Care Research Centre |
| Condition | Blood Loss Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-09-20 |
| Primary Completion | 2025-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-09-20 with a primary completion date of 2025-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients receiving ECMO * Age: 18 years or older 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 * ECMO treatment for more than 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 is defined as the arrival time into the initial ICU. * The treating physician anticipates that ECMO treatment will cease before the end of tomorrow * Where the treating physician deems the study is not in the patient's best interest * Where the treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds * Patients actively listed for a solid organ transplant * Patients who are suspected or confirmed to be pregnant * Previous ECMO treatment during the same hospital admission
Contact & Investigator
Hergen Buscher, MBBS
PRINCIPAL INVESTIGATOR
St Vincent's Hospital, Sydney
Frequently Asked Questions
Who can join the NCT05814094 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Blood Loss Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05814094 currently recruiting?
Yes, NCT05814094 is actively recruiting participants. Contact the research team at anzicrc@monash.edu for enrollment information.
Where is the NCT05814094 trial being conducted?
This trial is being conducted at Camperdown, Australia, Sydney, Australia.
Who is sponsoring the NCT05814094 clinical trial?
NCT05814094 is sponsored by Australian and New Zealand Intensive Care Research Centre. The principal investigator is Hergen Buscher, MBBS at St Vincent's Hospital, Sydney. The trial plans to enroll 120 participants.