Red Blood Cell Transfusion in ECMO - A Feasibility Trial

What this Trial Is About

Researchers are evaluating the safety and feasibility of two different red blood cell (RBC) transfusion strategies in patients receiving Extracorporeal Membrane Oxygenation (ECMO), a temporary mechanical support for heart or lung function in critically ill patients. The study aims to find out whether maintaining lower hemoglobin (Hb) levels (above 70 g/L) compared to higher levels (above 90 g/L) is safe and feasible for ECMO patients, who often experience anemia and require transfusions. This research addresses the lack of evidence on optimal transfusion thresholds specifically for ECMO patients, who have unique oxygen delivery challenges. Participants are randomly assigned to one of two groups: a restrictive transfusion strategy group where RBC transfusions are given if Hb falls to 70 g/L or less, and a liberal transfusion strategy group where transfusions are given if Hb falls to 90 g/L or less. Transfusions are administered within 12 hours of detecting these Hb levels, with additional units given as needed to raise Hb above the respective thresholds. The study will monitor if there is at least a 10 g/L difference in average lowest daily Hb between the two groups, assessing feasibility before a larger trial begins. During the study, participants will be closely monitored for Hb levels daily up to 28 days after randomization. Researchers will track transfusion timing, frequency, and any adverse events such as bleeding or thromboembolic complications. Patient-reported outcomes related to disability, cognitive function, and quality of life will be collected up to six months. The trial includes safety monitoring, enrollment tracking, and documentation of any protocol deviations, with an average study duration of about two years for data collection.

Red Blood Cell Transfusion in ECMO - A Feasibility Trial