ROSETTA
Red Blood Cell Transfusion in ECMO – a feasibility trial
A registry-embedded, randomised, open label, feasibility trial comparing two different red cell transfusion strategies in patients on ECMO.
Aim:
To determine the safety and feasibility of randomising patients on ECMO to a restrictive RBC transfusion trigger strategy (maintain Hb concentration ≥70g/L) or to a more liberal transfusion trigger strategy (maintain Hb concentration ≥90g/L).
Rationale:
Many critically ill ECMO patients have an increased risk of bleeding and reduced production/increased destruction of red blood cells (RBCs). This can lead to anaemia (haemoglobin levels (Hb) <120 g/l), a condition where a person's body lacks enough healthy RBCs to carry enough oxygen to the body’s tissues. Because of this, patients in ICU on ECMO frequently require RBC transfusion. Clinicians have to regularly decide if the risk/benefit of administering an RBC transfusion is higher than tolerating complications of anaemia.
Currently, the Australian Blood Authority’s guidelines recommend an RBC transfusion to a patient at an Hb concentration of <70 g/L, while a transfusion at a Hb between 70 and 90 g/L should be based on the need to relieve clinical signs and symptoms of anaemia. However, this range is broad, and many studies in the general critically ill cohort have shown lower transfusion triggers are non-inferior to higher transfusion triggers.
No studies have been completed directly evaluating transfusion triggers in the ECMO patient cohort. ECMO patients differ to the general critically ill cohort as they have different physiological requirements, are at higher risk for poor outcomes, and have an increased requirement for transfusions. Therefore, studies must be done to evaluate the optimal transfusion triggers that optimise mortality and long-term outcomes of ECMO patients.
Study Progress:
Participant recruitment commenced in September 2023. A target of 120 participants will be enrolled at participating sites across Australia. Recruitment is expected to be finished by January 2025.
Trial Registration:
https://clinicaltrials.gov/study/NCT05814094