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Search / Trial NCT05814094

Red Blood Cell Transfusion in ECMO - A Feasibility Trial

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Apr 3, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Hb Rbc Transfusion Ecmo Feasibility Safety Blood Transfusion Australia Blood Products Icu Critical Care Intensive Care Bleeding Transfusion Hb Values

ClinConnect Summary

The ROSETTA trial is studying how best to manage red blood cell (RBC) transfusions in patients receiving Extracorporeal Membrane Oxygenation (ECMO), a treatment that helps support patients with severe heart or lung problems. Many patients on ECMO experience anemia, which means they don't have enough healthy red blood cells to carry oxygen throughout their body. The trial aims to see if it is safer and more effective to give fewer RBC transfusions (keeping hemoglobin levels above 70g/L) compared to giving more transfusions (keeping hemoglobin levels above 90g/L). The goal is to determine if they can safely maintain a clear difference in hemoglobin levels between the two groups of patients.

To participate in this study, patients must be at least 18 years old and currently receiving ECMO. Certain patients may not be eligible, such as those who cannot receive RBC transfusions or those whose doctors believe the study may not be in their best interest. If eligible, participants will be randomly assigned to one of the two transfusion strategies and closely monitored throughout the trial. This research is important as it may help improve care for critically ill patients on ECMO by providing clearer guidelines on when to use red blood cell transfusions.

Gender

ALL

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

About Australian And New Zealand Intensive Care Research Centre

The Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) is a leading research organization dedicated to improving outcomes in critically ill patients through innovative clinical trials and research initiatives. Based at Monash University, the Centre fosters collaborative partnerships among clinicians, researchers, and institutions across Australia and New Zealand. Its focus on evidence-based practice and translational research aims to enhance the quality of intensive care, drive advancements in treatment protocols, and ultimately improve patient care in the intensive care unit (ICU) setting. ANZIC-RC is committed to addressing key challenges in critical care medicine, ensuring that findings from its trials contribute to better health outcomes and inform clinical guidelines globally.

Locations

Camperdown, New South Wales, Australia

Sydney, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Hergen Buscher, MBBS

Principal Investigator

St Vincent's Hospital, Sydney

Zoe McQuilten, PhD

Principal Investigator

Monash University

Carol Hodgson, PhD

Principal Investigator

Monash University

Alistair Nichol, PhD

Principal Investigator

Monash University

Aidan Burrell, MBBS

Principal Investigator

Monash University

Mark Dennis, MBBS

Principal Investigator

Royal Prince Alfred Hospital, Sydney, Australia

Timothy Southwood, MBBS

Principal Investigator

Royal Prince Alfred Hospital, Sydney, Australia

Alisa Higgins, PhD

Principal Investigator

Monash University

Sally Newman, Nursing

Principal Investigator

St Vincent's Hospital, Sydney

Thao Le, PhD

Principal Investigator

Monash University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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