A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

Официальное название

Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Primary Lung Graft Dysfunction (PGD) grade 3 [Срок оценки: 48-72 hours]
• Mortality [Срок оценки: 90 days]
• Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality [Срок оценки: 48-72 hours and 90 days]

Вторичные конечные точки (12)

• Red blood cell transfusions [Срок оценки: Intraoperative plus the first 24 hours in the ICU]
• Chest tube output [Срок оценки: First 24 hours]
• Incidence of re-exploration for bleeding [Срок оценки: First 48 hours]
• Incidence of air emboli [Срок оценки: During VA ECMO run]
• Incidence of stroke [Срок оценки: 90 days or discharge from the index hospitalization]
• Incidence of Primary Lung Graft Dysfunction (PGD) grade 3 [Срок оценки: At 0 hours (ICU arrival) and 24 hours]
• Incidence of pneumonia [Срок оценки: 90 days or discharge from the index hospitalization]
• Incidence of need for dialysis [Срок оценки: 90 days or discharge from the index hospitalization]
• Incidence of transplant rejection [Срок оценки: 90 days or discharge from the index hospitalization]
• Incidence of bronchial dehiscence [Срок оценки: 90 days or discharge from the index hospitalization]
• Incidence of tracheostomy [Срок оценки: 90 days or discharge from the index hospitalization]
• Length of mechanical ventilation [Срок оценки: 90 days or discharge from the index hospitalization]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• University Of Louisville — Louisville
• Mayo Clinic Rochester — Rochester
• Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT05547698 · 22-005691

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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