A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation
Start Date
9/17/2022
Completion Date
9/1/2027
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Off-pump lung transplantation
Venoarterial ECMO lung transplantation
Conditions
Locations
University Of Louisville
Louisville, Kentucky 40202
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Baylor College of Medicine
Houston, Texas 77030
United States