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

What this Trial Is About

Researchers are evaluating two different techniques for performing bilateral lung transplantation: the off-pump method and the use of venoarterial extracorporeal membrane oxygenation (VA ECMO). This trial aims to determine which technique results in lower rates of primary graft dysfunction, a serious complication after lung transplantation. Previous studies have shown conflicting results about which approach may be better, so this prospective randomized trial seeks to provide clearer answers. Participants will undergo lung transplantation using either the off-pump technique or the VA ECMO technique, both delivered as part of standard care. The off-pump procedure involves general anesthesia, lung removal, implantation, reperfusion, and ventilation without the use of ECMO. In contrast, the VA ECMO approach includes ECMO cannulation and support during the surgery before decannulation and closure. The trial compares these two procedures directly. Throughout the study, participants will be monitored closely for primary lung graft dysfunction at 48 to 72 hours and mortality at 90 days. Additional assessments include blood transfusions, chest tube output, bleeding complications, incidence of air embolism, stroke, pneumonia, dialysis need, transplant rejection, and length of mechanical ventilation and hospital stay. These comprehensive evaluations will help researchers understand the outcomes and safety of each transplantation method over the follow-up period extending to 90 days after surgery.

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