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Search / Trial NCT06868823

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

Lung Transplantation Extracorporeal Membrane Oxygenation (Ecmo) Anticoagulation Low Molecular Weight Heparin (Lmwh) Unfractionated Heparin (Ufh) Thrombosis Prevention Bleeding Complications Coagulation Management In Surgery Hemorrhagic And Thrombotic Events Perioperative Hemostasis

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.

Locations

Prague, , Czech Republic

Prague, Czech Republic, Czechia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported