Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE

What this Trial Is About

This trial evaluates two different red blood cell transfusion strategies in patients receiving veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. The study compares an individualized transfusion approach guided by central venous oxygen saturation (ScVO2) levels with a conventional approach based on a fixed hemoglobin threshold. It aims to reduce red blood cell consumption while monitoring mortality, morbidity, and cost-effectiveness in this critical care setting. Patients are randomly assigned to one of two groups: the individualized group receives transfusions only if ScVO2 drops below 65% after optimizing oxygen saturation, volume, ECMO output, fever, anxiety, and pain; the conventional group receives transfusions when hemoglobin falls below 9 g/dL. Transfusions may also be given in both groups during massive bleeding, severe anemia, or worsening neurological status. The study lasts up to 28 days from randomization or until VA-ECMO support ends. Participants undergo daily assessments including blood tests for hemoglobin and ScVO2, monitoring of oxygen delivery, vasoactive support, organ functions, and adverse events. Outcomes include the number of red blood cell units transfused per day, mortality at 28 and 90 days, complications such as sepsis and kidney injury, length of hospital stay, and cost-effectiveness analysis up to five years. Safety and treatment effects are closely followed throughout the study period.

Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO