Clinical trial Recruiting at 9 sites Interventional Ages 18 and up

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.

More Lung Transplant trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment228 (estimated)
SponsorMayo Clinic
Academic / other
Locations10 sites (Los Angeles, California and 9 other locations)
StatusRecruiting
StartedSeptember 17, 2022
Main results expectedSeptember 2028
Study endsSeptember 2029
Registry record updatedSeptember 10, 2026
Trial IDNCT05547698 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

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.

    Recruiting at 19 sites Duke University · Los Angeles, California and 18 other locations · NCT06399302

  • 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.

    Recruiting The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Palermo, Palermo · NCT07870811

  • 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.

    Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07516379

  • 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.

    Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07035743

  • 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.

    Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07017608

  • 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.

    Recruiting University Hospital, Gasthuisberg · Leuven, Vlaams-Brabant · NCT06959056

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.