Comparing Bivalirudin and Heparin for Anticoagulation in Adults on Extracorporeal Membrane Oxygenation ECMO A Randomized Phase 2b Trial Evaluating Safety, Effectiveness, and Cost

What this Trial Is About

Researchers are comparing two anticoagulation treatments, Bivalirudin and Unfractionated Heparin, for adults needing extracorporeal membrane oxygenation ECMO support. This Phase 2b open-label randomized trial aims to find which anticoagulant maintains blood thinning within a target range better, while also assessing bleeding, clotting problems, and the overall cost of care. The study is sponsored by Sydney Local Health District and addresses the lack of randomized trial data for anticoagulants during ECMO. Participants will be randomly assigned to receive either Bivalirudin with a target activated thromboplastin time aPTT of 50-70 seconds or Unfractionated Heparin targeting anti-Xa levels of 0.3-0.5 IUmL. The trial evaluates the effectiveness of these two anticoagulation protocols over the study period. During the 30-day study, researchers will monitor how long patients stay within the therapeutic range, track bleeding and clotting events, record anticoagulation costs, and observe other outcomes such as survival to ICU and hospital discharge. The trial includes assessments of adverse events, blood product use, and protocol adherence to provide comprehensive safety and effectiveness data for the treatments.

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation