Study Comparing Low-Molecular-Weight Heparin and Unfractionated Heparin for Anticoagulation During Lung Transplantation with ECMO Support

What this Trial Is About

This research aims to compare the safety and effectiveness of low-molecular-weight heparin LMWH versus unfractionated heparin UFH for anticoagulation during perioperative veno-arterial extracorporeal membrane oxygenation ECMO support in patients undergoing bilateral lung transplantation. The study explores whether LMWH can reduce bleeding and thrombotic complications compared to the standard UFH treatment. This pilot observational study involves 40 patients divided into two groups receiving either LMWH or UFH anticoagulation strategies. Participants assigned to the UFH group receive a bolus of 20-40 IUkg UFH 30 minutes before ECMO starts, followed by a continuous infusion. The LMWH group receives a similar bolus and infusion of Enoxaparin-based LMWH. Both groups have their coagulation monitored in real time using ROTEM tests and undergo standard laboratory and point-of-care coagulation assessments. In cases of significant blood loss, a detailed bleeding management protocol including administration of recombinant activated factor VIIa and other blood products is initiated. During the study, patients are closely evaluated for perioperative blood loss, changes in hemoglobin levels, blood transfusion requirements, and thrombotic events both during surgery and within 24 hours afterward. Additional coagulation profiles are assessed using thrombin generation tests and various laboratory parameters at multiple timepoints. The study ensures informed consent and careful monitoring to assess the comparative safety and effectiveness of the two anticoagulation methods over the perioperative period.

Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation