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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Motol

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

Sponsors and collaborators