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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Off-Pump Bilateral Lung Transplantation | Active Comparator | Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care |
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| Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation | Active Comparator | Subjects will receive VA ECMO technique for lung transplantation as part of standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Off-pump lung transplantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mortality | Death rate of subjects following lung transplantation | 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 | 48-72 hours and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Red blood cell transfusions | Number of subjects to require red blood cell transfusions | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauricio Villavicencio, MD, MBA | Contact | 507-2557068 | villavicencio.mauricio@mayo.edu | |
| Jackie Reiter | Contact | 507-538-2224 | reiter.jacqulyn@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mauricio Villavicencio, MD, MBA | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Label | URL |
|---|---|
| Mayo Research Clinical Trials | View source |
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| Venoarterial ECMO lung transplantation | Procedure | 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. |
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| First 24 hours |
| Incidence of re-exploration for bleeding | Number of subject to require re-exploration for bleeding | First 48 hours |
| Incidence of air emboli | Number of subjects to experience air emboli | During VA ECMO run |
| Incidence of stroke | Number of subjects to experience stroke | 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 | At 0 hours (ICU arrival) and 24 hours |
| Incidence of pneumonia | Number of subjects to experience pneumonia | 90 days or discharge from the index hospitalization |
| Incidence of need for dialysis | Number of subjects to need dialysis | 90 days or discharge from the index hospitalization |
| Incidence of transplant rejection | Number of subjects to experience transplant rejection | 90 days or discharge from the index hospitalization |
| Incidence of bronchial dehiscence | Number of subjects to experience bronchial dehiscence | 90 days or discharge from the index hospitalization |
| Incidence of tracheostomy | Number of subjects to require tracheostomy | 90 days or discharge from the index hospitalization |
| Length of mechanical ventilation | Total amount of time subjects require mechanical ventilation following lung transplantation | 90 days or discharge from the index hospitalization |
| Length of stay | Total amount of time subjects are hospitalized | 90 days or discharge from the index hospitalization |
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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