Anticoagulation-free VV ECMO for Acute Respiratory Failure: A Pilot Safety and Feasibility Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating the safety and feasibility of an anticoagulation-free strategy for adults with acute respiratory distress syndrome (ARDS) who require veno-venous extracorporeal membrane oxygenation (VV-ECMO). This pilot study addresses the current practice of therapeutic anticoagulation, which varies worldwide but typically uses unfractionated heparin, and explores the possibility that anticoagulation may not be necessary during VV-ECMO due to lower risk of systemic embolization compared to other ECMO types. The study randomly assigns participants to one of two groups: one group will receive no unfractionated heparin during ECMO but will get standard venous thromboembolism prevention with subcutaneous heparin or enoxaparin, while the other group will receive the standard anticoagulation with intravenous unfractionated heparin during ECMO. The trial compares these approaches over an average ECMO duration of 14 days. Participants will be monitored for complications related to ECMO, including thrombotic and hemorrhagic events, throughout the treatment period. Various assessments and safety evaluations will be conducted during ECMO support, with a focus on measuring thrombotic complications as the primary outcome. The total participation involves the ECMO treatment duration and related clinical follow-up for safety and feasibility assessments.

Anticoagulation-free VV ECMO for Acute Respiratory Failure