ECSTATIC

The ECSTATIC trial employs a robust multicenter, non-inferiority randomized controlled design to compare two prophylactic platelet transfusion strategies in non-bleeding pediatric ECMO patients. Specifically, children are randomized into one of two arms: a higher platelet threshold strategy, where transfusion is initiated when the platelet count drops below 90 x 10e9/L, and a lower threshold strategy, where transfusion occurs when the count falls below 50 x 10e9/L. The trial's open-label format is balanced by blinded adjudication of outcomes, ensuring objective evaluation of results.

The primary outcome is the proportion of patients progressing from no bleeding or minimal bleeding to severe bleeding or thrombosis. Secondary outcomes include complications like hemorrhagic and thrombotic events (as defined by the Extracorporeal Life Support Organization), total blood product exposure, duration of ECMO support, length of PICU stay, functional outcomes at discharge (measured by Pediatric Overall Performance Category and Pediatric Cerebral Performance Category), and mortality at 28 and 90 days.

The significance of the ECSTATIC trial lies in its potential to directly impact clinical practice by offering evidence-based guidelines for platelet transfusion in pediatric ECMO patients. Current guidelines rely heavily on expert opinion due to a lack of high-quality evidence, which has contributed to variability in practice. Observational studies have shown that prophylactic platelet transfusions, though intended to prevent bleeding, may paradoxically increase the risk of thrombosis and mortality. Therefore, identifying an optimal transfusion strategy is essential to reducing unnecessary transfusions and their associated risks while ensuring that bleeding is effectively prevented. The findings from this trial will not only inform platelet transfusion practices but may also contribute to broader transfusion medicine guidelines, impacting care in critical pediatric settings globally