Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
Launched by UNIVERSITY HOSPITAL, MOTOL · Mar 4, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether a medication called low-molecular-weight heparin (LMWH) is as safe and effective as unfractionated heparin (UFH) for preventing blood clots during a procedure known as ECMO in patients receiving new lungs through lung transplantation. The study aims to find out if using LMWH can lead to less bleeding and fewer clot-related problems compared to UFH. Patients who are adults and are having a bilateral lung transplant with ECMO support may be eligible to participate, as long as they meet certain criteria, such as not having severe bleeding disorders or needing ECMO for an extended time after surgery.
If you or a loved one are eligible and choose to participate, you will be assigned to one of two groups: one will receive UFH and the other will receive LMWH during the procedure. The researchers will monitor things like blood loss and the need for blood transfusions, as well as check how the blood is clotting. This study is currently not recruiting participants, but it aims to help determine the best anticoagulation strategy for lung transplant patients in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. ⃣ Adults (≥18 years old).
- • 2. ⃣ Patients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support.
- • 3. ⃣ Planned perioperative anticoagulation with either UFH or LMWH, as determined by the attending anesthesiologist.
- • 4. ⃣ Ability to provide informed consent or consent provided by a legally authorized representative.
- Exclusion Criteria:
- • 1. ⃣ Patients receiving ECMO as a bridge to lung transplantation.
- • 2. ⃣ Patients requiring postoperative continuation of ECMO.
- • 3. ⃣ Patients with perioperative blood loss ≥3,000 mL.
- • 4. ⃣ Patients undergoing lung re-transplantation.
- • 5. ⃣ History of severe coagulopathy or bleeding disorder.
- • 6. ⃣ Active use of antiplatelet or anticoagulant therapy (excluding study anticoagulants).
- • 7. ⃣ Known heparin-induced thrombocytopenia (HIT).
- • 8. ⃣ Severe liver dysfunction (Child-Pugh C) or end-stage renal disease requiring dialysis.
- • 9. ⃣ Pregnant or breastfeeding women.
About University Hospital, Motol
University Hospital Motol is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. Located in Prague, Czech Republic, the hospital is affiliated with Charles University and serves as a key institution for medical education and training. With a robust focus on patient-centered care, University Hospital Motol conducts a wide range of clinical studies across various specialties, aiming to improve treatment outcomes and enhance the understanding of complex medical conditions. The hospital's commitment to excellence in research, combined with its state-of-the-art facilities and multidisciplinary expertise, positions it at the forefront of clinical trial initiatives in the region.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Prague, , Czech Republic
Prague, Czech Republic, Czechia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported