LMWH versus UFH for ECMO anticoagulation during bilateral lung transplant
Official title: LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation: A Prospective, Observational, and Pilot Study
Run by University Hospital, Motol · NCT06868823 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Motol Academic / other |
| Locations | 1 site (Prague, Czech Republic) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | June 10, 2025 |
| Trial ID | NCT06868823 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: miroslav.durila@fnmoto.cz
- Phone: +420224435440
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.