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Red Blood Cell Transfusion in ECMO - A Feasibility Trial

Study acronym: ROSETTA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary completion date changed from estimate of Dec 30, 2024 to Jan 30, 2025
    • Study completion date: Mar 30, 2025 to Dec 30, 2025
    • Site contacts updated at 1 of 2 sites
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 60 to 120
    • Start date changed from estimate of May 2023 to Sep 20, 2023
    • Study sites: 0 to 2
    • Primary completion date: Aug 2024 to Dec 30, 2024
    • Study completion date: Mar 2025 to Mar 30, 2025
    • Study description expanded, about 84 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05814094
Lead Sponsor Australian and New Zealand Intensive Care Research Centre
Conditions
(from sponsor)
Blood Loss Anemia, Extracorporeal Membrane Oxygenation Complication, Disability Physical, Cognitive Ability, General, Functional Status
Related terms Hemorrhage
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov