NCT05547698

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Transplant

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2022-09-17
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2022-09-21
• Last updated: 2025-04-20

Locations

5 sites across 1 country: United States