Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
Trial Parameters
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Brief Summary
The aim of this observational pilot study is to evaluate the effectiveness and safety of low-molecular-weight heparin (LMWH) compared to unfractionated heparin (UFH) as anticoagulation in perioperative ECMO during bilateral lung transplantation. The main question this study seeks to answer is: Does LMWH provide a safe and effective alternative to UFH for ECMO anticoagulation in lung transplantation, with reduced bleeding and thrombotic complications? Patients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support will be assigned to one of two anticoagulation strategies: UFH group: Standard UFH anticoagulation monitored using ROTEM. LMWH group: Enoxaparin-based anticoagulation monitored using ROTEM. The study will assess perioperative blood loss, hemoglobin levels, transfusion needs, and thrombotic events. Additional analyses will include coagulation profile assessments using point-of-care (POC) tests, thrombin generation test (TGT), and laboratory coagulation parameters.
Eligibility Criteria
Inclusion Criteria: 1. ⃣ Adults (≥18 years old). 2. ⃣ Patients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support. 3. ⃣ Planned perioperative anticoagulation with either UFH or LMWH, as determined by the attending anesthesiologist. 4. ⃣ Ability to provide informed consent or consent provided by a legally authorized representative. Exclusion Criteria: 1. ⃣ Patients receiving ECMO as a bridge to lung transplantation. 2. ⃣ Patients requiring postoperative continuation of ECMO. 3. ⃣ Patients with perioperative blood loss ≥3,000 mL. 4. ⃣ Patients undergoing lung re-transplantation. 5. ⃣ History of severe coagulopathy or bleeding disorder. 6. ⃣ Active use of antiplatelet or anticoagulant therapy (excluding study anticoagulants). 7. ⃣ Known heparin-induced thrombocytopenia (HIT). 8. ⃣ Severe liver dysfunction (Child-Pugh C) or end-stage renal disease requiring dialysis. 9. ⃣ Pregnant or breastfeeding women.