A Novel Strategy Combining Regional Anticoagulation in Membrane Oxygenator and Low-intensity Systemic Anticoagulation for ECMO Management

What this Trial Is About

This research aims to improve anticoagulation management in patients using extracorporeal membrane oxygenation (ECMO) for severe respiratory and/or circulatory failure. ECMO treatment is linked to a high rate of bleeding and clotting complications, which significantly increase the risk of death. Optimizing the way anticoagulation is controlled during ECMO is an urgent scientific priority to reduce these adverse events. The study compares two anticoagulation approaches during ECMO. One group receives a combination of nafamostat and unfractionated heparin, with doses adjusted to keep blood clotting times at specific target ranges both systemically and within the ECMO membrane lung. The other group receives only unfractionated heparin with doses adjusted to maintain blood clotting time within a higher target range during ECMO. Participants are randomly assigned to one of these treatment groups. Participants will be closely monitored for bleeding or clotting events related to ECMO over a 28-day period. The study will measure how often these complications occur as the primary outcome. Researchers will track anticoagulation levels through blood tests to adjust medication doses. The entire trial is planned to run until December 31, 2027, with ongoing safety and effectiveness assessments throughout the study period.

A Novel Strategy of ECMO Management Using Nafamostat for Regional Combined With Low Intensity Systematic Anticoagulation