LMWH versus UFH for ECMO anticoagulation during bilateral lung transplant

LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation: A Prospective, Observational, and Pilot Study

This will see if low-molecular-weight heparin (enoxaparin) works as a safe and effective alternative to unfractionated heparin for blood thinning during ECMO around bilateral lung transplantation.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Motol (Academic / other)
• Locations: 1 site (Prague, Czech Republic)
• Trial ID: NCT06868823 on ClinicalTrials.gov

What this trial studies

This is a prospective observational pilot comparing perioperative anticoagulation strategies in adults undergoing bilateral lung transplantation with veno-arterial ECMO support. Patients receive either standard unfractionated heparin (UFH) or enoxaparin-based low-molecular-weight heparin (LMWH) as determined by the treating team, with anticoagulation monitored using ROTEM. The study records perioperative blood loss, hemoglobin, transfusion requirements, and thrombotic events, and performs detailed coagulation testing including point-of-care assays and thrombin generation tests. Results will be used to inform whether LMWH is a viable alternative to UFH in this setting and to design larger comparative trials if promising.

Who should consider this trial

Good fit: Adults undergoing planned bilateral lung transplantation with perioperative veno-arterial ECMO who can provide informed consent and whose perioperative anticoagulation will be managed with either UFH or LMWH are the intended participants.

Not a fit: Patients bridged to transplant, requiring postoperative continuation of ECMO, with massive perioperative blood loss, severe coagulopathy, active non-study anticoagulant or antiplatelet use, known HIT, severe liver failure, dialysis-dependent renal failure, or pregnancy/breastfeeding are not expected to benefit or be eligible.

Why it matters

Potential benefit: If successful, LMWH could reduce bleeding and clotting complications and lower transfusion needs during perioperative ECMO in lung transplant patients.

How similar studies have performed: Small case series and observational reports have suggested LMWH can be used safely for ECMO anticoagulation without obvious circuit thrombosis, but large randomized trials are lacking.

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.

Where this trial is running

Prague, Czech Republic

• 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 (Recruiting)

Study contacts

• Study coordinator: Miroslav Durila, prof. M.D., Ph.D., MHA

Conditions Lung Transplantation; Extracorporeal Membrane Oxygenation; Anticoagulants and Bleeding Disorders; Anticoagulation; Low-Molecular-Weight Heparin; Unfractionated Heparin; Thrombosis Prevention; Bleeding Complications