RecruitingNot Applicable

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

United States228 participantsStarted 2022-09-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Primary Lung Graft Dysfunction (PGD) grade 3

Timeframe: 48-72 hours

Mortality

Timeframe: 90 days

Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality

Timeframe: 48-72 hours and 90 days

Trial details

NCT IDNCT05547698

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Mauricio Villavicencio, MD, MBA

507-2557068 villavicencio.mauricio@mayo.edu

View on ClinicalTrials.gov More Lung Transplant trials