LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation: A Prospective, Observational, and Pilot Study
Status: Recruiting
Study Type: Observational
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.
• ⃣ 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.
Contact Information
Primary
Miroslav Durila, prof. M.D., Ph.D., MHA
miroslav.durila@fnmoto.cz
+420224435440
Backup
Gabriela Holubova, M.D.
gabriela.holubova@fnmotol.cz
+420224435440
Time Frame
Start Date:2025-05-01
Estimated Completion Date:2025-12-31
Participants
Target number of participants:40
Treatments
UFH Anticoagulation Group
Participants in this group will receive unfractionated heparin (UFH) as the standard anticoagulation regimen during perioperative veno-arterial (V-A) ECMO support for bilateral lung transplantation.~UFH Administration:~A bolus of 20-40 IU/kg UFH will be administered 30 minutes before ECMO initiation.~Continuous UFH infusion of 2-6 mL/h (dilution: 100 mg/50 mL) will be maintained.~Coagulation Monitoring:~ROTEM (EXTEM, INTEM, HEPTEM, FIBTEM) will be used for real-time assessment. The target CT INTEM/CT HEPTEM ratio will be maintained at 1.2-1.5 to guide anticoagulation adjustments.~Coagulation and Hemostasis Assessments:~Standard laboratory coagulation tests (aPTT, PT, TT, fibrinogen, FXIII, D-dimers, anti-Xa, platelet count, hemoglobin, hematocrit) will be performed at predefined timepoints.~Point-of-care (POC) testing and thrombin generation test (TGT) will be used for additional evaluation.
LMWH Anticoagulation Group
Participants in this group will receive low-molecular-weight heparin (LMWH) as an alternative anticoagulation strategy during perioperative veno-arterial (V-A) ECMO support for bilateral lung transplantation.~LMWH Administration:~A bolus of 20-40 IU/kg LMWH (Enoxaparin) will be administered 30 minutes before ECMO initiation.~Continuous LMWH infusion of 2-6 mL/h (dilution: 100 mg/50 mL) will be maintained.~Coagulation Monitoring:~ROTEM (EXTEM, INTEM, HEPTEM, FIBTEM) will be used for real-time assessment. The CT INTEM/CT HEPTEM difference will be maintained at 20-30 seconds to guide anticoagulation adjustments.~Coagulation and Hemostasis Assessments:~Standard laboratory coagulation tests (aPTT, PT, TT, fibrinogen, FXIII, D-dimers, anti-Xa, platelet count, hemoglobin, hematocrit) will be performed at predefined timepoints.~Point-of-care (POC) testing and thrombin generation test (TGT) will be used for additional evaluation.