Blood Loss AnemiaROSETTANCT05814094
Red Blood Cell Transfusion in ECMO - A Feasibility Trial
A study testing Red Blood Cell Transfusion in people with Blood Loss Anemia and Extracorporeal Membrane Oxygenation Complication, run by Australian and New Zealand Intensive Care Research Centre at 2 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Loss Anemia, Extracorporeal Membrane Oxygenation Complication, Disability Physical
- What is being tested?
- Red Blood Cell Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- 20 Sep 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients receiving ECMO
- Age: 18 years or older
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Heidi Buhr, +61 2 9515 6007, heidi.buhr@health.nsw.gov.au
Timothy Southwood
- Recruiting
St Vincent's Health Sydney
Sydney, New South Wales, 2010
Hergen Buscher, A/Prof, hergen.buscher@svhs.org.au
About this study
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.
Read the detailed description
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.
- Conditions
- Blood Loss Anemia, Extracorporeal Membrane Oxygenation Complication, Disability Physical, Cognitive Ability, General, Functional Status
- Being tested
- Red Blood Cell Transfusion
- Keywords
- Hb, RBC transfusion, ECMO, feasibility, safety, blood transfusion, Australia, blood products, ICU, critical care, intensive care, bleeding, transfusion, Hb values
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Blood Cell TransfusionOther
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.
Red Blood Cell TransfusionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive Transfusion Trigger Group | Active comparator | 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. Receives: Other: Red Blood Cell Transfusion |
| Liberal Transfusion Trigger Group | Active comparator | 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 Receives: Other: Red Blood Cell Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in average lowest daily Hb concentration
Primary Outcome Measure
Measured: From date of randomization to the end of the intervention (assessed up to day 28)
Secondary outcomes (23)
Enrolment Rate
Feasibility Outcome
Measured: through study completion, an average of 2 years
Reasons for not entering eligible patients into the study
Feasibility Outcome
Measured: through study completion, an average of 2 years
Mean pre-transfusion Hb concentration immediately prior to an RBC transfusion
Feasibility Outcome
Measured: through study completion, an average of 2 years
Proportion of RBC transfusions given according to allocated trigger
Feasibility Outcome
Measured: through study completion, an average of 2 years
Time from measured Hb trigger value to transfusion
Feasibility Outcome
Measured: through study completion, an average of 2 years
Number of RBC transfusions given prior to randomization
Feasibility Outcome
Measured: through study completion, an average of 2 years
Frequency for not transfusing a patient who has reached a transfusion trigger
Feasibility Outcome
Measured: through study completion, an average of 2 years
Reason/s for not transfusing a patient who has reached a transfusion trigger
Feasibility Outcome
Measured: through study completion, an average of 2 years
Number of protocol deviations
Feasibility Outcome
Measured: through study completion, an average of 2 years
Number and nature of Serious Adverse Events (SAEs)
Safety and effectiveness outcome
Measured: through study completion, an average of 2 years
Total blood products used
Safety and effectiveness outcome
Measured: through study completion, an average of 2 years
Major bleeding events (defined by ISTH criteria)
Safety and effectiveness outcome
Measured: 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
Measured: through study completion, an average of 2 years
Venous and arterial thromboembolic events
Safety and effectiveness outcome
Measured: through study completion, an average of 2 years
New onset renal replacement therapy (RRT) during ECMO
Safety and effectiveness outcome
Measured: through study completion, an average of 2 years
ECMO free days at day 60
Safety and effectiveness outcome
Measured: 60 days
ICU free days at day 60
Safety and effectiveness outcome
Measured: 60 days
Patient Reported Outcome Measure - WHODAS 2.0
Disability Safety and effectiveness outcome
Measured: 6 months
Patient Reported Outcome Measure - IADL
Independent Activities of Daily Living Safety and effectiveness outcome
Measured: 6 months
Patient Reported Outcome Measure - ADL
Activity of Daily Living Safety and effectiveness outcome
Measured: 6 months
Patient Reported Outcome Measure - MoCA BLIND
Cognitive Function Safety and effectiveness outcome
Measured: 6 months
Patient Reported Outcome Measure - EQ-5D-5L
Quality of Life Safety and effectiveness outcome
Measured: 6 months
Patient Reported Outcome Measure - mRS
Degree of Disability Safety and effectiveness outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Sep 2023
- Primary completion30 Jan 2025
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hergen Buscher, MBBS, Principal investigator, St Vincent's Hospital, SydneyZoe McQuilten, PhD, Principal investigator, Monash UniversityCarol Hodgson, PhD, Principal investigator, Monash UniversityAlistair Nichol, PhD, Principal investigator, Monash UniversityAidan Burrell, MBBS, Principal investigator, Monash UniversityMark Dennis, MBBS, Principal investigator, Royal Prince Alfred Hospital, Sydney, AustraliaTimothy Southwood, MBBS, Principal investigator, Royal Prince Alfred Hospital, Sydney, AustraliaAlisa Higgins, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814094
- Sponsor's protocol ID
- ANZIC-RC/HB001
- Acronym
- ROSETTA
- Status last verified
- May 2025
- First submitted
- 22 Nov 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is de-identified and only aggregate summaries published.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Transfusion in ECMO - A Feasibility Trial
- ClinicalTrials.gov ID
- NCT05814094
- Acronym / sponsor ID
- ROSETTA / ANZIC-RC/HB001
- Conditions
- Blood Loss Anemia, Extracorporeal Membrane Oxygenation Complication, Disability Physical, Cognitive Ability, General, Functional Status
- Keywords
- Hb, RBC transfusion, ECMO, feasibility, safety, blood transfusion, Australia, blood products
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive Transfusion Trigger Group | Active comparator | Other: Red Blood Cell Transfusionif 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. |
| Liberal Transfusion Trigger Group | Active comparator | Other: Red Blood Cell Transfusionif 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving ECMO
- Age: 18 years or older
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Blood Cell TransfusionFollowing 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. | Other | Restrictive Transfusion Trigger Group |
| Red Blood Cell TransfusionFollowing 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. | Other | Liberal Transfusion Trigger Group |
Primary outcome
Difference in average lowest daily Hb concentration
Time frame: From date of randomization to the end of the intervention (assessed up to day 28)
Primary Outcome Measure
23 secondary outcomes
Enrolment Rate
Time frame: through study completion, an average of 2 years
Reasons for not entering eligible patients into the study
Time frame: through study completion, an average of 2 years
Mean pre-transfusion Hb concentration immediately prior to an RBC transfusion
Time frame: through study completion, an average of 2 years
Proportion of RBC transfusions given according to allocated trigger
Time frame: through study completion, an average of 2 years
Time from measured Hb trigger value to transfusion
Time frame: through study completion, an average of 2 years
Number of RBC transfusions given prior to randomization
Time frame: through study completion, an average of 2 years
Frequency for not transfusing a patient who has reached a transfusion trigger
Time frame: through study completion, an average of 2 years
Reason/s for not transfusing a patient who has reached a transfusion trigger
Time frame: through study completion, an average of 2 years
Number of protocol deviations
Time frame: through study completion, an average of 2 years
Number and nature of Serious Adverse Events (SAEs)
Time frame: through study completion, an average of 2 years
Total blood products used
Time frame: through study completion, an average of 2 years
Major bleeding events (defined by ISTH criteria)
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
Time frame: through study completion, an average of 2 years
Venous and arterial thromboembolic events
Time frame: through study completion, an average of 2 years
New onset renal replacement therapy (RRT) during ECMO
Time frame: through study completion, an average of 2 years
ECMO free days at day 60
Time frame: 60 days
ICU free days at day 60
Time frame: 60 days
Patient Reported Outcome Measure - WHODAS 2.0
Time frame: 6 months
Patient Reported Outcome Measure - IADL
Time frame: 6 months
Patient Reported Outcome Measure - ADL
Time frame: 6 months
Patient Reported Outcome Measure - MoCA BLIND
Time frame: 6 months
Patient Reported Outcome Measure - EQ-5D-5L
Time frame: 6 months
Patient Reported Outcome Measure - mRS
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No. Patient data is de-identified and only aggregate summaries published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hergen Buscher, MBBS principal investigator
St Vincent's Hospital, Sydney
Zoe McQuilten, PhD principal investigator
Monash University
Carol Hodgson, PhD principal investigator
Monash University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Blood Cell Transfusion in people with Blood Loss Anemia and Extracorporeal Membrane Oxygenation Complication, run by Australian and New Zealand Intensive Care Research Centre at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Curtis Hopkins, B.BioMed, MPH, MHA (+61 3 9903 0343, anzicrc@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in average lowest daily Hb concentration (time frame: From date of randomization to the end of the intervention (assessed up to day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.