Red Blood Cell Transfusion in ECMO - A Feasibility 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). 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

Interventions

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.

OTHER

Red Blood Cell Transfusion

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.

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre

  lead OTHER

Principal Investigators

• Hergen Buscher, MBBS · St Vincent's Hospital, Sydney

• Zoe McQuilten, PhD · Monash University

• Carol Hodgson, PhD · Monash University

• Alistair Nichol, PhD · Monash University

• Aidan Burrell, MBBS · Monash University

• Mark Dennis, MBBS · Royal Prince Alfred Hospital, Sydney, Australia

• Timothy Southwood, MBBS · Royal Prince Alfred Hospital, Sydney, Australia

• Alisa Higgins, PhD · Monash University

• Sally Newman, Nursing · St Vincent's Hospital, Sydney

• Thao Le, PhD · Monash University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-20

Primary Completion

2025-01-30

Completion

2025-12-30

Countries

• Australia

Study Locations