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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
228
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.
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.
University Of Louisville
Louisville, Kentucky, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
Primary Lung Graft Dysfunction (PGD) grade 3
Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification
Time frame: 48-72 hours
Mortality
Death rate of subjects following lung transplantation
Time frame: 90 days
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
Time frame: 48-72 hours and 90 days
Red blood cell transfusions
Number of subjects to require red blood cell transfusions
Time frame: Intraoperative plus the first 24 hours in the ICU
Chest tube output
Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc)
Time frame: First 24 hours
Incidence of re-exploration for bleeding
Number of subject to require re-exploration for bleeding
Time frame: First 48 hours
Incidence of air emboli
Number of subjects to experience air emboli
Time frame: During VA ECMO run
Incidence of stroke
Number of subjects to experience stroke
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Temple University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGTime frame: 90 days or discharge from the index hospitalization
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
Time frame: At 0 hours (ICU arrival) and 24 hours
Incidence of pneumonia
Number of subjects to experience pneumonia
Time frame: 90 days or discharge from the index hospitalization
Incidence of need for dialysis
Number of subjects to need dialysis
Time frame: 90 days or discharge from the index hospitalization
Incidence of transplant rejection
Number of subjects to experience transplant rejection
Time frame: 90 days or discharge from the index hospitalization
Incidence of bronchial dehiscence
Number of subjects to experience bronchial dehiscence
Time frame: 90 days or discharge from the index hospitalization
Incidence of tracheostomy
Number of subjects to require tracheostomy
Time frame: 90 days or discharge from the index hospitalization
Length of mechanical ventilation
Total amount of time subjects require mechanical ventilation following lung transplantation
Time frame: 90 days or discharge from the index hospitalization
Length of stay
Total amount of time subjects are hospitalized
Time frame: 90 days or discharge from the index hospitalization