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

Recruiting

Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Off-pump lung transplantation (procedure)
Venoarterial ECMO lung transplantation (procedure)

Sponsor: Mayo Clinic · Participants: 228 · Started: Sep 17, 2022

Contact the study team

Mauricio Villavicencio, MD, MBA · Phone: 507-2557068
Jackie Reiter · Phone: 507-538-2224

Official record on ClinicalTrials.gov — NCT05547698

Locations in the U.S.

California	Cedar's Sinai, Los Angeles
Georgia	Emory University, Atlanta (Not yet recruiting)
Kentucky	University Of Louisville, Louisville
Maryland	Johns Hopkins, Baltimore
Minnesota	Mayo Clinic Rochester, Rochester
Ohio	Ohio State University, Columbus
Pennsylvania	Temple University, Philadelphia
Texas	UT Southwestern, Dallas Baylor College of Medicine, Houston

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.