Comparing off-pump lung transplantation to venoarterial ECMO lung transplantation
Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
NA · Mayo Clinic · NCT05547698
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 3 sites (Louisville, Kentucky and 2 other locations) |
| Trial ID | NCT05547698 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals eligible for bilateral lung transplantation who meet specific pulmonary artery pressure criteria.
Not a fit: Patients who are undergoing single lung transplants or have had previous major lung surgeries may not benefit from this study.
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 performed: Previous studies have shown mixed results regarding the effectiveness of VA ECMO compared to off-pump techniques, making this a critical and novel investigation.
Eligibility criteria
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 this trial is running
Louisville, Kentucky and 2 other locations
- University Of Louisville — Louisville, Kentucky, United States (RECRUITING)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (RECRUITING)
- Baylor College of Medicine — Houston, Texas, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Transplant, Bilateral