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

Recruiting now

Conditions studied: Lung Transplantation, Extracorporeal Membrane Oxygenation (ECMO), Anticoagulants and Bleeding Disorders

In brief

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.

Key facts

Study ID

NCT06868823

Run by

University Hospital, Motol

People needed

40

Starts

2025-05-01

Expected to finish

2025-12-31

Last updated by the study team

2025-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ⃣ 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.

You may not qualify if…

• ⃣ 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.

Where it is running

• University Hospital Motol, 2nd Faculty of Medicine, Charles University in Prague and 3rd Department of Surgery, First Faculty of Medicine, Charles University, and Motol University Hospital, Lung Transplant Program — Prague, Czech Republic, Czechia (enrolling)

Full record on ClinicalTrials.gov

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