Lung TransplantNCT05547698
A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation
A study testing Off-pump lung transplantation and Venoarterial ECMO lung transplantation in people with Lung Transplant, run by Mayo Clinic at 10 sites in 2 countries.
Trial summary
The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Off-pump lung transplantation and Venoarterial ECMO lung transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 17 Sep 2022to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States9 sites, 9 recruiting
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Maialen Odriozola, 404-686-5500
Muath Bishawti, MD
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21287
Errol Bush, 443-997-1508
Daniel Kudaya, dkudaya1@jh.edu
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Bryan Whitson, MD, 6142934967, bryan.whitson@osumc.edu
Josefina Summers, josefina.summers@osumc.edu
- Recruiting
UT Southwestern
Dallas, Texas, 75235
Suresh Keshavamurthy, MD, 214-645-7551, Suresh.keshavamurthy@utsouthwestern.edu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Gabriel Loor, MD, 832-355-3000, gabriel.loor@bcm.edu
Gabriel Loor
- Recruiting
Cedar's Sinai
Los Angeles, California, 90048
Dominick Megna, MD, 310-423-2726
Andrea Dubon, Andrea.Dubon@cshs.org
- Recruiting
University Of Louisville
Louisville, Kentucky, 40202
Matthew Fox, Dr., 502-587-4384
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Jennie Wong, 215-707-0061, jennie.wong@tuhs.temple.edu
Yoshiya Toyoda, MD, 2157077692, Yoshiya.Toyoda@tuhs.temple.edu
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Mauricio Villavicencio Theoduloz, MD, MBA, 507-255-7068, villavicencio.mauricio@mayo.edu
Jacqulyn R Reiter, 507-538-2224, reiter.jacqulyn@mayo.edu
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven
Laurens Ceulemans, MD, 3216332211, laurens.ceulemans@uzleuven.be
About this study
Official title: Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.
Read the detailed description
The Investigators of the Extracorporeal Life Support Registry in Lung Transplantation (ECLS Registry) has studied the impact of the type of intraoperative extracorporeal life support on primary graft dysfunction (PGD) after lung transplantation (LTx) in an international registry. The investigators have demonstrated that severe PGD at 48-72 hours is greater when LTx is performed using cardiopulmonary bypass (CPB) (43%) when compared to veno-arterial (VA) ECMO. However, PGD after VA ECMO remained high (29%) when compared to off-pump (12%). Conversely, there are retrospective series showing that when compared to off-pump technique, VA ECMO has reduced PGD rates and improved survival. Because selection bias and unknown confounders in retrospective studies could have been the cause of these conflicting results, part of the ECLS Registry Investigators are committed to a prospective multicenter randomized trial comparing off-pump versus VA ECMO LTx.
- Conditions
- Lung Transplant
- Being tested
- Off-pump lung transplantation, Venoarterial ECMO lung transplantation
- Keywords
- Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-pump lung transplantationProcedure or surgery
General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, pneumonectomy starting by the less perfused lung in the scan, stump preparation, lung implantation, reperfusion, gradual release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, chest closure.
Venoarterial ECMO lung transplantationProcedure or surgery
General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, heparin, peripheral or central venoarterial ECMO cannulation, first pneumonectomy, stump preparation, lung implantation, reperfusion, release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, ECMO decannulation, chest closure.
| Study group | Role | What they receive |
|---|---|---|
| Off-Pump Bilateral Lung Transplantation | Active comparator | Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care Receives: Procedure: Off-pump lung transplantation |
| Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation | Active comparator | Subjects will receive VA ECMO technique for lung transplantation as part of standard of care Receives: Procedure: Venoarterial ECMO lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Lung Graft Dysfunction (PGD) grade 3
Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification
Measured: 48-72 hours
Mortality
Death rate of subjects following lung transplantation
Measured: 90 days
Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality
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
Measured: 48-72 hours and 90 days
Secondary outcomes (13)
Red blood cell transfusions
Number of subjects to require red blood cell transfusions
Measured: Intraoperative plus the first 24 hours in the ICU
Chest tube output
Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc)
Measured: First 24 hours
Incidence of re-exploration for bleeding
Number of subject to require re-exploration for bleeding
Measured: First 48 hours
Incidence of air emboli
Number of subjects to experience air emboli
Measured: During VA ECMO run
Incidence of stroke
Number of subjects to experience stroke
Measured: 90 days or discharge from the index hospitalization
Incidence of Primary Lung Graft Dysfunction (PGD) grade 3
Number of subjects to experience a PGD grade 3 following lung transplantation. PGD will be rated according to the The International Society for Heart and Lung Transplantation (ISHLT) classification
Measured: At 0 hours (ICU arrival) and 24 hours
Incidence of pneumonia
Number of subjects to experience pneumonia
Measured: 90 days or discharge from the index hospitalization
Incidence of need for dialysis
Number of subjects to need dialysis
Measured: 90 days or discharge from the index hospitalization
Incidence of transplant rejection
Number of subjects to experience transplant rejection
Measured: 90 days or discharge from the index hospitalization
Incidence of bronchial dehiscence
Number of subjects to experience bronchial dehiscence
Measured: 90 days or discharge from the index hospitalization
Incidence of tracheostomy
Number of subjects to require tracheostomy
Measured: 90 days or discharge from the index hospitalization
Length of mechanical ventilation
Total amount of time subjects require mechanical ventilation following lung transplantation
Measured: 90 days or discharge from the index hospitalization
Length of stay
Total amount of time subjects are hospitalized
Measured: 90 days or discharge from the index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start17 Sep 2022
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio A. Villavicencio Theoduloz, Mayo Clinic
- Investigators
- Mauricio Villavicencio, MD, MBA, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547698
- Sponsor's protocol ID
- 22-005691
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05547698
- Acronym / sponsor ID
- 22-005691
- Conditions
- Lung Transplant
- Keywords
- Bilateral
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Sep 2022 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.
Detailed description
The Investigators of the Extracorporeal Life Support Registry in Lung Transplantation (ECLS Registry) has studied the impact of the type of intraoperative extracorporeal life support on primary graft dysfunction (PGD) after lung transplantation (LTx) in an international registry. The investigators have demonstrated that severe PGD at 48-72 hours is greater when LTx is performed using cardiopulmonary bypass (CPB) (43%) when compared to veno-arterial (VA) ECMO. However, PGD after VA ECMO remained high (29%) when compared to off-pump (12%). Conversely, there are retrospective series showing that when compared to off-pump technique, VA ECMO has reduced PGD rates and improved survival. Because selection bias and unknown confounders in retrospective studies could have been the cause of these conflicting results, part of the ECLS Registry Investigators are committed to a prospective multicenter randomized trial comparing off-pump versus VA ECMO LTx.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-Pump Bilateral Lung Transplantation | Active comparator | Procedure: Off-pump lung transplantationSubjects will receive 'off-pump' technique for lung transplantation as part of standard of care |
| Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation | Active comparator | Procedure: Venoarterial ECMO lung transplantationSubjects will receive VA ECMO technique for lung transplantation as part of standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Single lung transplant
- Multiorgan transplant.
- Donor after cardiac death (DCD).
- Re-transplant.
- Intention to use prophylactic post-operative ECMO.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Off-pump lung transplantationGeneral anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, pneumonectomy starting by the less perfused lung in the scan, stump preparation, lung implantation, reperfusion, gradual release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, chest closure. | Procedure or surgery | Off-Pump Bilateral Lung Transplantation |
| Venoarterial ECMO lung transplantationGeneral anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, heparin, peripheral or central venoarterial ECMO cannulation, first pneumonectomy, stump preparation, lung implantation, reperfusion, release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, ECMO decannulation, chest closure. | Procedure or surgery | Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation |
Primary outcome
Primary Lung Graft Dysfunction (PGD) grade 3
Time frame: 48-72 hours
Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification
Mortality
Time frame: 90 days
Death rate of subjects following lung transplantation
Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality
Time frame: 48-72 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
13 secondary outcomes
Red blood cell transfusions
Time frame: Intraoperative plus the first 24 hours in the ICU
Chest tube output
Time frame: First 24 hours
Incidence of re-exploration for bleeding
Time frame: First 48 hours
Incidence of air emboli
Time frame: During VA ECMO run
Incidence of stroke
Time frame: 90 days or discharge from the index hospitalization
Incidence of Primary Lung Graft Dysfunction (PGD) grade 3
Time frame: At 0 hours (ICU arrival) and 24 hours
Incidence of pneumonia
Time frame: 90 days or discharge from the index hospitalization
Incidence of need for dialysis
Time frame: 90 days or discharge from the index hospitalization
Incidence of transplant rejection
Time frame: 90 days or discharge from the index hospitalization
Incidence of bronchial dehiscence
Time frame: 90 days or discharge from the index hospitalization
Incidence of tracheostomy
Time frame: 90 days or discharge from the index hospitalization
Length of mechanical ventilation
Time frame: 90 days or discharge from the index hospitalization
Length of stay
Time frame: 90 days or discharge from the index hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Mayo Research Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mauricio Villavicencio, MD, MBA principal investigator
Mayo Clinic
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Off-pump lung transplantation and Venoarterial ECMO lung transplantation in people with Lung Transplant, run by Mayo Clinic at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauricio Villavicencio, MD, MBA (507-2557068, villavicencio.mauricio@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Lung Graft Dysfunction (PGD) grade 3 (time frame: 48-72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.