A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation
NCT ID: NCT05547698
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
228 participants
INTERVENTIONAL
2022-09-17
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Off-Pump Bilateral Lung Transplantation
Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care
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 Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation
Subjects will receive VA ECMO technique for lung transplantation as part of standard of care
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Mean pulmonary artery pressure \< or = 35 mmHg.
* Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mauricio A. Villavicencio Theoduloz
Principal Investigator
Principal Investigators
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Mauricio Villavicencio, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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University Of Louisville
Louisville, Kentucky, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Matthew Fox, Dr.
Role: primary
Christian Bermudez, Dr.
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-005691
Identifier Type: -
Identifier Source: org_study_id
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