NCT Number: NCT05547698
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University Of Louisville, Louisville, Kentucky, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48-72 hours
Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification
Time frame: 90 days
Death rate of subjects following lung transplantation
Time frame: 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
Time frame: Intraoperative plus the first 24 hours in the ICU
Number of subjects to require red blood cell transfusions
Time frame: First 24 hours
Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc)
Time frame: First 48 hours
Number of subject to require re-exploration for bleeding
Time frame: During VA ECMO run
Number of subjects to experience air emboli
Time frame: 90 days or discharge from the index hospitalization
Number of subjects to experience stroke
Time frame: 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
Time frame: 90 days or discharge from the index hospitalization
Number of subjects to experience pneumonia
Time frame: 90 days or discharge from the index hospitalization
Number of subjects to need dialysis
Time frame: 90 days or discharge from the index hospitalization
Number of subjects to experience transplant rejection
Time frame: 90 days or discharge from the index hospitalization
Number of subjects to experience bronchial dehiscence
Time frame: 90 days or discharge from the index hospitalization
Number of subjects to require tracheostomy
Time frame: 90 days or discharge from the index hospitalization
Total amount of time subjects require mechanical ventilation following lung transplantation
Time frame: 90 days or discharge from the index hospitalization
Total amount of time subjects are hospitalized
Contact information is provided by the study sponsor or research team.
Jackie Reiter
CONTACT
Mauricio Villavicencio, MD, MBA
CONTACT
Mayo Clinic
Other
Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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