Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation: A Prospective, Observational, and Pilot Study
University Hospital, Motol
40 participants
May 1, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- ⃣ Adults (≥18 years old).
- ⃣ Patients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support.
- ⃣ Planned perioperative anticoagulation with either UFH or LMWH, as determined by the attending anesthesiologist.
- ⃣ Ability to provide informed consent or consent provided by a legally authorized representative.
Exclusion Criteria9
- ⃣ Patients receiving ECMO as a bridge to lung transplantation.
- ⃣ Patients requiring postoperative continuation of ECMO.
- ⃣ Patients with perioperative blood loss ≥3,000 mL.
- ⃣ Patients undergoing lung re-transplantation.
- ⃣ History of severe coagulopathy or bleeding disorder.
- ⃣ Active use of antiplatelet or anticoagulant therapy (excluding study anticoagulants).
- ⃣ Known heparin-induced thrombocytopenia (HIT).
- ⃣ Severe liver dysfunction (Child-Pugh C) or end-stage renal disease requiring dialysis.
- ⃣ Pregnant or breastfeeding women.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06868823