Lung Transplant
Conditions
Keywords
Bilateral
Brief 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.
Interventions
PROCEDUREOff-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.
PROCEDUREVenoarterial 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Lung Graft Dysfunction (PGD) grade 3 | 48-72 hours | Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification |
| Mortality | 90 days | Death rate of subjects following lung transplantation |
| Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality | 48-72 hours and 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Red blood cell transfusions | Intraoperative plus the first 24 hours in the ICU | Number of subjects to require red blood cell transfusions |
| Chest tube output | First 24 hours | Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc) |
| Incidence of re-exploration for bleeding | First 48 hours | Number of subject to require re-exploration for bleeding |
| Incidence of air emboli | During VA ECMO run | Number of subjects to experience air emboli |
| Incidence of stroke | 90 days or discharge from the index hospitalization | Number of subjects to experience stroke |
| Incidence of Primary Lung Graft Dysfunction (PGD) grade 3 | At 0 hours (ICU arrival) and 24 hours | 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 |
| Incidence of pneumonia | 90 days or discharge from the index hospitalization | Number of subjects to experience pneumonia |
| Incidence of need for dialysis | 90 days or discharge from the index hospitalization | Number of subjects to need dialysis |
| Incidence of transplant rejection | 90 days or discharge from the index hospitalization | Number of subjects to experience transplant rejection |
| Incidence of bronchial dehiscence | 90 days or discharge from the index hospitalization | Number of subjects to experience bronchial dehiscence |
| Incidence of tracheostomy | 90 days or discharge from the index hospitalization | Number of subjects to require tracheostomy |
| Length of mechanical ventilation | 90 days or discharge from the index hospitalization | Total amount of time subjects require mechanical ventilation following lung transplantation |
| Length of stay | 90 days or discharge from the index hospitalization | Total amount of time subjects are hospitalized |
Countries
Belgium, United States
Contacts
CONTACTMauricio Villavicencio, MD, MBA
CONTACTJackie Reiter
PRINCIPAL_INVESTIGATORMauricio Villavicencio, MD, MBA
Mayo Clinic
Outcome results
None listed