Actively Recruiting
Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
Led by University Hospital, Motol · Updated on 2025-06-10
40
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 decided by the anesthesiologist
- Ability to provide informed consent or consent from a legally authorized representative
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
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, 150 06
Actively Recruiting
Research Team
M
Miroslav Durila, prof. M.D., Ph.D., MHA
CONTACT
G
Gabriela Holubova, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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