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

Lung Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547698
• Other study ID #: 22-005691
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2022
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Mauricio Villavicencio, MD, MBA
• Phone: 507-2557068
• Email: villavicencio.mauricio[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplant

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover
United States	Baylor College of Medicine	Houston	Texas
United States	University Of Louisville	Louisville	Kentucky
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Lung Graft Dysfunction (PGD) grade 3	Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification	48-72 hours
Primary	Mortality	Death rate of subjects following lung transplantation	90 days
Primary	Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality	Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification plus the Death rate of subjects following lung transplantation	48-72 hours and 90 days
Secondary	Red blood cell transfusions	Number of subjects to require red blood cell transfusions	Intraoperative plus the first 24 hours in the ICU
Secondary	Chest tube output	Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc)	First 24 hours
Secondary	Incidence of re-exploration for bleeding	Number of subject to require re-exploration for bleeding	First 48 hours
Secondary	Incidence of air emboli	Number of subjects to experience air emboli	During VA ECMO run
Secondary	Incidence of stroke	Number of subjects to experience stroke	90 days or discharge from the index hospitalization
Secondary	Incidence of Primary Lung Graft Dysfunction (PGD) grade 3	Number of subjects to experience a PGD grade 3 following lung transplantation. PGD will be rated according to the The International Society for Heart and Lung Transplantation (ISHLT) classification	At 0 hours (ICU arrival) and 24 hours
Secondary	Incidence of pneumonia	Number of subjects to experience pneumonia	90 days or discharge from the index hospitalization
Secondary	Incidence of need for dialysis	Number of subjects to need dialysis	90 days or discharge from the index hospitalization
Secondary	Incidence of transplant rejection	Number of subjects to experience transplant rejection	90 days or discharge from the index hospitalization
Secondary	Incidence of bronchial dehiscence	Number of subjects to experience bronchial dehiscence	90 days or discharge from the index hospitalization
Secondary	Incidence of tracheostomy	Number of subjects to require tracheostomy	90 days or discharge from the index hospitalization
Secondary	Length of mechanical ventilation	Total amount of time subjects require mechanical ventilation following lung transplantation	90 days or discharge from the index hospitalization
Secondary	Length of stay	Total amount of time subjects are hospitalized	90 days or discharge from the index hospitalization