Red Blood Cell Transfusion in ECMO - A Feasibility Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients receiving ECMO

• Age: 18 years or older

Locations
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
St Vincent's Health Sydney
RECRUITING
Sydney
Contact Information
Primary
Curtis Hopkins, B.BioMed, MPH, MHA
anzicrc@monash.edu
+61 3 9903 0343
Time Frame
Start Date: 2023-09-20
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 120
Treatments
Active_comparator: Restrictive Transfusion Trigger Group
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.
Active_comparator: Liberal Transfusion Trigger Group
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
Related Therapeutic Areas
Sponsors
Leads: Australian and New Zealand Intensive Care Research Centre

This content was sourced from clinicaltrials.gov

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