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

Launched by MAYO CLINIC · Sep 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of performing a lung transplant: one method uses a special machine called venoarterial ECMO (VA ECMO) to support the heart and lungs, while the other method is done off-pump, meaning it doesn't use this machine. The main goal of the study is to see which method leads to fewer problems with the new lungs after the transplant, specifically looking at a condition called primary graft dysfunction, where the transplanted lungs don’t function well right after surgery.

To be eligible for this trial, participants need to be receiving a bilateral lung transplant (meaning both lungs are being transplanted) and have a certain level of blood pressure in the lungs (specifically, it should be 35 mmHg or lower). The trial is open to all genders and is currently looking for participants aged between 65 and 74. If you or a loved one are considering participating, you can expect close monitoring during the study to assess how well each method works and to ensure safety throughout the process. It’s important to note that some individuals, such as those who have had a single lung transplant or certain types of previous surgeries, may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.