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.
⃣ 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.
⃣ 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.
The study population will consist of patients indicated for bilateral lung transplantation from the Czech Republic and Slovakia, who will undergo surgery at Motol Hospital in Prague.
Case-control
Prospective
Not listed
Perioperative Blood Loss
Total volume of blood lost (milliliters, mL) during surgery, measured as the volume collected in suction canisters at the end of the operation, after subtracting irrigation fluids.
Change in Hemoglobin Levels during surgery and within 24 hours after surgery
The difference in hemoglobin levels (g/L) measured at baseline (preoperative) and at the end of surgery and between immediate postoperative levels and after 24 hours after surgery. This outcome evaluates the extent of perioperative blood loss and its impact on oxygen-carrying capacity.
Blood Transfusion Requirements during surgery and Within 24 Hours after surgery
The total number of packed red blood cell (PRBC) units transfused to the patient intraoperatively and within the first 24 hours postoperatively. This outcome assesses the extent of blood loss and the need for transfusion support in ECMO-supported lung transplantation.
Incidence of Thrombotic Complications during surhery and within 24 Hours postoperatively.
The number of thrombotic events occurring intraoperatively and within the first 24 hours postoperatively, including ECMO circuit thrombosis, deep vein thrombosis (DVT), arterial thrombosis, pulmonary embolism (PE), myocardial infarction (MI), and ischemic stroke (CVA). Thrombotic complications will be identified based on clinical signs, imaging studies, and laboratory results, including: ECMO circuit thrombosis requiring urgent ECMO replacement. Limb ischemia due to arterial or venous thrombosis. Deep vein thrombosis (DVT) with \>50% luminal obstruction, confirmed by ultrasound. Pulmonary embolism (PE) confirmed by CT pulmonary angiography. Myocardial infarction (MI) diagnosed based on electrocardiographic changes and cardiac biomarkers. Ischemic stroke (CVA) confirmed by neurological examination and brain imaging (CT/MRI).
Coagulation Profile Assessed by Point-of-Care (POC) Tests
Assessment of coagulation function using point-of-care (POC) testing, including ROTEM Sigma and PFA-200, to evaluate differences in hemostatic profiles between LMWH and UFH anticoagulation strategies during perioperative ECMO support in lung transplantation. ROTEM Sigma: EXTEM, INTEM, FIBTEM, HEPTEM-parameters CT (seconds), CFT (seconds), MCF (mm), ML (%) PFA-200: Col/EPI test for platelet function assessment of CT in seconds
Coagulation Profile Assessed by Thrombin Generation Test (TGT)
Evaluation of coagulation potential and thrombin generation capacity using the Thrombin Generation Test (TGT) to compare the effects of LMWH vs. UFH on hemostatic function in ECMO-supported lung transplantation. Key parameters measured: Lag time (initiation of thrombin formation) in minutes. Peak thrombin concentration (maximum thrombin level) in nanomolar. Time to peak (speed of thrombin generation) in minutes. Endogenous thrombin potential (ETP) (total thrombin formed) in nanomolar minutes.
Coagulation Profile Assessed by Standard Laboratory Tests
Assessment of coagulation status using standard laboratory tests to evaluate differences in hemostatic profiles between LMWH and UFH anticoagulation strategies in ECMO-supported lung transplantation. Blood samples will be analyzed for standard coagulation parameters, including: Activated partial thromboplastin time (aPTT) in seconds. Prothrombin time (PT) in seconds. Thrombin time (TT) in seconds. Fibrinogen levels in g/L. Factor XIII (FXIII) levels in %. D-dimers in mg/L FEU. Fibrin monomers (FM) in mg/L. Antithrombin activity in %. Anti-Xa level in IU/mL. Platelet count x109/L Hemoglobin in g/L.
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