Comparing off-pump lung transplantation to venoarterial ECMO lung transplantation
Official title: Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
Run by Mayo Clinic · NCT05547698 · Data updated 2026-11-12
This study is testing two different methods for lung transplantation to see which one leads to fewer problems with the new lungs after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 228 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Status | Recruiting |
| Started | September 17, 2022 |
| Main results expected | September 2028 |
| Study ends | September 2029 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT05547698 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals eligible for bilateral lung transplantation who meet specific pulmonary artery pressure criteria.
✕Probably not a fit
Patients who are undergoing single lung transplants or have had previous major lung surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare two techniques for bilateral lung transplantation: off-pump lung transplantation and venoarterial ECMO (VA ECMO). The research focuses on evaluating which method results in lower rates of primary graft dysfunction (PGD) post-surgery. By utilizing a prospective multicenter randomized approach, the study seeks to address conflicting results from previous retrospective analyses regarding the effectiveness of these techniques. The trial is part of the Extracorporeal Life Support Registry in Lung Transplantation, which has previously highlighted the impact of intraoperative support on PGD rates.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and lower rates of primary graft dysfunction for patients undergoing lung transplantation.
How similar studies have gone: Previous studies have shown mixed results regarding the effectiveness of VA ECMO compared to off-pump techniques, making this a critical and novel investigation.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Cedar's Sinai
Los Angeles, California, United States Recruiting -
University Of Louisville
Louisville, Kentucky, United States Recruiting -
Johns Hopkins
Baltimore, Maryland, United States Recruiting -
Mayo Clinic Rochester
Rochester, Minnesota, United States Recruiting -
Ohio State University
Columbus, Ohio, United States Recruiting -
Temple University
Philadelphia, Pennsylvania, United States Recruiting
Show 4 more locations
-
UT Southwestern
Dallas, Texas, United States Recruiting -
Baylor College of Medicine
Houston, Texas, United States Recruiting -
UZ Leuven
Leuven, Belgium Recruiting -
Emory University
Atlanta, Georgia, United States Not yet recruiting
Study contacts
- Principal investigator: Mauricio Villavicencio, MD, MBA — Mayo Clinic
- Study coordinator: Mauricio Villavicencio, MD, MBA
- Email: villavicencio.mauricio@mayo.edu
- Phone: 507-2557068
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Research on improving outcomes for lung transplant donors and recipients
This study is trying to see how different donor and medical practices affect the health of lung transplant patients and donors, while also looking for blood markers that might predict complications after the surgery.
-
Multidisciplinary non-drug program to improve quality of life after solid organ transplant
A multidisciplinary, non-drug program using acupuncture, remote physical rehab, and brain-health activities is being tested to see if it can improve quality of life for adults at least one year after heart, kidney, liver, or lung transplant.
-
Multimodal prospective approach to understand acute and chronic lung transplant rejection
This project will see if blood tests, airway sampling, imaging, and genetic analyses can identify which adults who have had or are being evaluated for a lung transplant will develop antibody‑mediated rejection and later chronic graft dysfunction.
-
Airway response to exercise after double lung transplant
This study will see if short (5-minute) versus longer (15-minute) constant-work exercise causes different airway narrowing and breathlessness in people who have had a double lung transplant.
-
Measuring breathing effort before and after removing the breathing tube
This will test a new electrical impedance method to measure breathing effort in adults on ventilators as they try breathing on their own and after the breathing tube is removed.
-
Cryo nerve block to improve recovery after bilateral lung transplant
This pilot will test whether adding a cryo nerve block around the chest helps people with end-stage COPD recover better after a bilateral lung transplant.
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.