Red Blood Cell Transfusion in ECMO - A Feasibility Trial

NCT05814094 | Recruiting

• 1 other identifier: ANZIC-RC/HB001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

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; ICU; critical care; intensive care; bleeding; transfusion; Hb values

Outcome Measures

Primary Outcomes (1)

• Difference in average lowest daily Hb concentration

  Primary Outcome Measure

  From date of randomization to the end of the intervention (assessed up to day 28)

Secondary Outcomes (23)

• Enrolment Rate

  through study completion, an average of 2 years

• Reasons for not entering eligible patients into the study

  through study completion, an average of 2 years

• Mean pre-transfusion Hb concentration immediately prior to an RBC transfusion

  through study completion, an average of 2 years

• Proportion of RBC transfusions given according to allocated trigger

  through study completion, an average of 2 years

• Time from measured Hb trigger value to transfusion

  through study completion, an average of 2 years

Study Arms (2)

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.

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

Other: Red Blood Cell Transfusion

Interventions

Red Blood Cell Transfusion OTHER

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.

Restrictive Transfusion Trigger Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving ECMO
• Age: 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

Study Sites (2)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

St Vincent's Health Sydney

Sydney, New South Wales, 2010, Australia

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Hergen Buscher, MBBS

  St Vincent's Hospital, Sydney

  PRINCIPAL INVESTIGATOR

• Zoe McQuilten, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

• Carol Hodgson, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

• Alistair Nichol, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

• Aidan Burrell, MBBS

  Monash University

  PRINCIPAL INVESTIGATOR

• Mark Dennis, MBBS

  Royal Prince Alfred Hospital, Sydney, Australia

  PRINCIPAL INVESTIGATOR

• Timothy Southwood, MBBS

  Royal Prince Alfred Hospital, Sydney, Australia

  PRINCIPAL INVESTIGATOR

• Alisa Higgins, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

• Sally Newman, Nursing

  St Vincent's Hospital, Sydney

  PRINCIPAL INVESTIGATOR

• Thao Le, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Curtis Hopkins, B.BioMed, MPH, MHA

CONTACT

+61 3 9903 0343; anzicrc@monash.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: April 14, 2023
• Study Start: September 20, 2023
• Primary Completion: January 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)