An interventional study of Red Blood Cell Transfusion and Red Blood Cell Transfusion in Blood Loss Anemia, Extracorporeal Membrane Oxygenation Complication and Disability Physical, sponsored by Australian and New Zealand Intensive Care Research Centre. Recruiting at 2 sites in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Australian and New Zealand Intensive Care Research Centre · Not applicable, Interventional, and Health services research
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.
A recent Cochrane analysis recommended a transfusion strategy that minimises the use of RBC transfusions in critically ill patients (by tolerating anaemia to avoid the adverse effects of an RBC transfusion). However, the analysis acknowledges that the degree of anaemia which can be tolerated by such patients is unknown, especially in patients suffering from conditions that limit oxygen delivery to the organs (like cardiac disease). As a result, the Australian Blood Authority's guidelines recommend an RBC transfusion to a patient at an Hb concentration of less than 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. Hb is a key driver of oxygen delivery (DO2), and critically ill ECMO patients are more commonly exposed to low DO2 due to low cardiac output and borderline oxygenation. Therefore, studies must be done to evaluate the optimal transfusion trigger/s (as determined by Hb concentration) that optimise mortality and long-term outcomes of ECMO patients.
Should the ROSSETTA Pilot results indicate adequate separation of at least 10g/L between the two study groups, and that patient safety has not been adversely affected by the trial methods, feasibility will be deemed confirmed and the protocol not in need of modification prior to full trial commencement. At this point the ROSETTA Pilot will be transitioned into the Red Blood Cell Transfusion Domain, within RECOMMEND Platform Trial. The Primary and Secondary outcomes of the trial at large, will be answered during this stage.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Australian and New Zealand Intensive Care Research Centre is the lead sponsor of 48 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
if a patient's Hb concentration reads ≤ 70g/L, one unit of RBC will be transfused. Additional units can be prescribed if required to raise the Hb concentration to above 70g/L.
Other: Red Blood Cell Transfusion
if a patient's Hb concentration reads ≤ 90g/L, one or more units of RBC will be transfused. Additional units can be prescribed to raise the Hb concentration to greater than 90g/L
Other: Red Blood Cell Transfusion
Following randomisation, if a patient's Hb concentration reads ≤ 70g/L, one unit of RBC will be transfused within 12 hours of the result becoming available. Additional units can be prescribed if required to raise the Hb concentration to above 70g/L. A transfusion above the restrictive threshold of 70g/L is discouraged.
Following randomisation, if a patient's Hb concentration reads ≤ 90g/L, one or more units of RBC will be transfused in order to raise the Hb concentration to greater than 90g/L within 12 hours of the result becoming available. A decision not to transfuse below the threshold of 90g/L is discouraged.
Difference in average lowest daily Hb concentration
Primary Outcome Measure
Time frame: From date of randomization to the end of the intervention (assessed up to day 28)
Enrolment Rate
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Reasons for not entering eligible patients into the study
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Mean pre-transfusion Hb concentration immediately prior to an RBC transfusion
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Proportion of RBC transfusions given according to allocated trigger
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Time from measured Hb trigger value to transfusion
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Number of RBC transfusions given prior to randomization
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Frequency for not transfusing a patient who has reached a transfusion trigger
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Reason/s for not transfusing a patient who has reached a transfusion trigger
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Number of protocol deviations
Feasibility Outcome
Time frame: through study completion, an average of 2 years
Number and nature of Serious Adverse Events (SAEs)
Safety and effectiveness outcome
Time frame: through study completion, an average of 2 years
Total blood products used
Safety and effectiveness outcome
Time frame: through study completion, an average of 2 years
Major bleeding events (defined by ISTH criteria)
Safety and effectiveness outcome
Time frame: through study completion, an average of 2 years
Clinically relevant non-major bleeding events: GI haemorrhage, peripheral cannulation site bleeding, mediastinal cannulation site bleeding, surgical site bleeding
Safety and effectiveness outcome
Time frame: through study completion, an average of 2 years
Venous and arterial thromboembolic events
Safety and effectiveness outcome
Time frame: through study completion, an average of 2 years
New onset renal replacement therapy (RRT) during ECMO
Safety and effectiveness outcome
Time frame: through study completion, an average of 2 years
ECMO free days at day 60
Safety and effectiveness outcome
Time frame: 60 days
ICU free days at day 60
Safety and effectiveness outcome
Time frame: 60 days
Patient Reported Outcome Measure - WHODAS 2.0
Disability Safety and effectiveness outcome
Time frame: 6 months
Patient Reported Outcome Measure - IADL
Independent Activities of Daily Living Safety and effectiveness outcome
Time frame: 6 months
Patient Reported Outcome Measure - ADL
Activity of Daily Living Safety and effectiveness outcome
Time frame: 6 months
Patient Reported Outcome Measure - MoCA BLIND
Cognitive Function Safety and effectiveness outcome
Time frame: 6 months
Patient Reported Outcome Measure - EQ-5D-5L
Quality of Life Safety and effectiveness outcome
Time frame: 6 months
Patient Reported Outcome Measure - mRS
Degree of Disability Safety and effectiveness outcome
Time frame: 6 months
Plan to share: No — Patient data is de-identified and only aggregate summaries published.
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Australian and New Zealand Intensive Care Research Centre