Recruiting

Off-Pump vs. VA ECMO

Sponsor:

Mayo Clinic

Code:

NCT05547698

Conditions

Lung Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Off-pump lung transplantation

Venoarterial ECMO lung transplantation

Study Details

Brief 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.

Conditions

Lung Transplant

Study ID

NCT05547698

Start date

Sep 17, 2022

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Off-Pump Bilateral Lung Transplantation

Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care

active comparator: Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation

Subjects will receive VA ECMO technique for lung transplantation as part of standard of care

Interventions

Off-pump lung transplantation

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 transplantation

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.

Primary outcome measure

  • Primary Lung Graft Dysfunction (PGD) grade 3 [ Time Frame: 48-72 hours ]
  • Mortality [ Time Frame: 90 days ]
  • Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality [ Time Frame: 48-72 hours and 90 days ]

Central Contacts and Locations

Central contacts

Mauricio Villavicencio, MD, MBA

507-2557068villavicencio.mauricio@mayo.edu

Jackie Reiter

507-538-2224reiter.jacqulyn@mayo.edu

Locations

University Of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Matthew Fox, Dr.

502-587-4384

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Mauricio Villavicencio Theoduloz, MD, MBA

507-255-7068villavicencio.mauricio@mayo.edu

Jacqulyn R Reiter

507-538-2224reiter.jacqulyn@mayo.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Bryan Whitson, MD

6142934967bryan.whitson@osumc.edu

Josefina Summers

josefina.summers@osumc.edu

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Jennie Wong

215-707-0061jennie.wong@tuhs.temple.edu

Yoshiya Toyoda, MD

2157077692Yoshiya.Toyoda@tuhs.temple.edu

UT Southwestern

Recruiting

Dallas, Texas, United States, 75235

Contacts

Suresh Keshavamurthy, MD

214-645-7551Suresh.keshavamurthy@utsouthwestern.edu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Gabriel Loor, MD

832-355-3000gabriel.loor@bcm.edu

Principal Investigator:

Gabriel Loor

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Bilateral

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-08.