Pilot Study Comparing Anticoagulation with Unfractionated Heparin, Argatroban, and Enoxaparin During Extracorporeal Membrane Oxygenation Support

What this Trial Is About

Researchers are evaluating different anticoagulation methods for patients requiring extracorporeal membrane oxygenation ECMO support due to respiratory or circulatory failure. This phase IV, randomized controlled pilot study compares the standard treatment using unfractionated heparin with two alternatives argatroban and enoxaparin. The goal is to determine if enoxaparin or argatroban are not worse than unfractionated heparin in preventing blood clots during ECMO therapy. Participants will be randomly assigned to one of three groups receiving anticoagulation during ECMO subcutaneous enoxaparin given twice daily at 0.5 mgkg, continuous intravenous argatroban infusion adjusted to target specific thrombin time levels, or continuous intravenous unfractionated heparin infusion adjusted to target anti-FXa levels. Anticoagulation treatment continues for the duration of ECMO support, which typically averages about 14 days. During the study, researchers will monitor participants for the occurrence of blood clots and bleeding events throughout their ECMO run. Assessments include regular measurements of clotting parameters to adjust medication doses appropriately. The primary outcome is the incidence of thromboembolic events during ECMO therapy. Participation involves close medical observation until ECMO support ends, with safety and treatment effectiveness closely tracked by the medical team.

Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support