A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

This study is comparing two different ways to perform a bilateral lung transplant (transplanting both lungs): "off-pump" lung transplantation and "venoarterial ECMO (VA ECMO)" lung transplantation. Researchers want to see which method leads to fewer cases of severe primary graft dysfunction (PGD), which is when the new lungs don't work well right after surgery. They will also look at survival rates. You might be able to join if you are an adult needing a bilateral lung transplant and meet certain health criteria, such as having a mean pulmonary artery pressure of 35 mmHg or less. The study is currently recruiting 228 participants, but its overall status is unclear.

Study design
This interventional study plans to enroll 228 participants to compare two surgical techniques for bilateral lung transplantation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for primary lung graft dysfunction at 48-72 hours and mortality at 90 days after the transplant.

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NCT05547698

A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

Recruiting
NAAges 18+InterventionalSupportive care
Mayo Clinic
~228 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Off-pump lung transplantationVenoarterial ECMO lung transplantation

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Lung Graft Dysfunction (PGD) grade 3
Measured over 48-72 hours
+2 more outcomes measured
Lung Transplant
3 sites across 3 states
Kentucky1
Minnesota1
Texas1
  • Mauricio Villavicencio, MD, MBA · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

Bilateral Lung Transplantation (LTx) recipients.
Mean pulmonary artery pressure \< or = 35 mmHg.
Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

Exclusion

Single lung transplant
Multiorgan transplant.
Donor after cardiac death (DCD).
Re-transplant.
Intention to use prophylactic post-operative ECMO.
Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion criterion.
Previous pleurodesis.
Preoperative ECMO and/or mechanical ventilation.
  • Primary Lung Graft Dysfunction (PGD) grade 348-72 hours

    Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification

  • Mortality90 days

    Death rate of subjects following lung transplantation

  • Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality48-72 hours and 90 days

    Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification plus the Death rate of subjects following lung transplantation