About this trial

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.

Eligibility criteria

Qualifiers

⃣ 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.

Disqualifiers

⃣ 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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

40 Participants
are grouped into 2 trial groups

Locations

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 Program150 06, PragueCzech Republic, Czechia

Sponsors and collaborators

University Hospital, Motol

Lead sponsor