Routine vs On-demand ECMO for Lung Transplantation

Официальное название

RoutinE Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation (ECMO) During LUng TransplantatION (REVOLUTION)

Обзор

Lung transplantation is a complex procedure performed in patients with terminal lung disease. The transplant procedure stresses the patient's heart and lungs, which are already taxed by the underlying disease process. The heart-lung machine is occasionally used to support the patient and ensure adequate oxygen supply to other organs during the operation. It can be used routinely in all patients or selectively in patients who exhibit reduced oxygen supply to the remaining organs. This process, known as cardiopulmonary bypass (CPB), pumps blood out of the body to a heart-lung machine that removes carbon dioxide and returns oxygen-filled blood to the body. Although using the CPB increases the risk of bleeding, infection, and coagulation complications, it should still be considered in high-risk patients to compensate for more severe complications such as kidney failure and stroke caused by a lack of cardiopulmonary support. Extracorporeal membrane oxygenation (ECMO) is a recently developed CPB variation associated with fewer bleeding complications. It has recently replaced the traditional heart-lung machine as the preferred method of cardiopulmonary support during lung transplantation. Since ECMO is associated with fewer complications than standard CPB, many centers have increased their use of ECMO during lung transplantation. Some have even employed it routinely. However, there remains significant debate on how often it should be used. Therefore, the study's main objective is to compare the two approaches in lung transplantation, i.e., routine use versus selective use, and to determine if one approach is preferable to the other.

Подробное описание

This study compares two approaches to intraoperative cardiopulmonary support during lung transplantation: routine cardiopulmonary support with extracorporeal membrane oxygenation (ECMO) versus selective use. Despite recent improvements in lung transplant outcomes, postoperative complications are common. Intraoperative hemodynamic management is vital to the success of lung transplantation. Many centers, including all four Canadian centers, use ECMO to provide intraoperative support. However, lung transplantation without cardiopulmonary support may be possible in certain patients. In such patients, the transplant may be started without ECMO. ECMO may be initiated "on-demand" if hemodynamic embarrassment or hypoxia occurs. Conversely, the opposite approach would be routinely conducting all lung transplants using ECMO. The current practice in many centers is to use ECMO selectively. By extension, the investigators believe that more liberal use of intraoperative ECMO will produce less intraoperative hemodynamic instability and hypoxia. However, it is unclear the extent of ECMO use necessary to improve the incidence of postoperative hypoperfusion-related complications. Should ECMO be used routinely in all patients or selectively based on the intraoperative course? The study is a prospective, randomized, controlled trial with two treatment arms: routine support with ECMO versus selective (on-demand) support with ECMO. Study population (Inclusion and exclusion criteria): All patients, 18 years of age or older, undergoing lung transplantation will be screened for participation. We will exclude patients who require intraoperative ECMO, multi-organ transplants, and retransplantation Arms and Interventions: On-demand ECMO: The transplant will be planned without cardiopulmonary support in this group. Intraoperative ECMO will be employed if there is an inability to maintain adequate organ perfusion and oxygen delivery despite resuscitation. Routine ECMO: Routine intraoperative ECMO in all patients, regardless of hemodynamic status. Primary outcome: Intensive care unit (ICU)-free days in the first 28 days post-lung transplant.

Вмешательства

• Устройство Routine ECMO
  Routine intraoperative venoarterial ECMO during lung transplant
• Устройство On-demand ECMO
  Selective, indication-based intraoperative cardiopulmonary support. In this group, the transplant will be planned without cardiopulmonary support. intraoperative venoarterial ECMO will be used selectively based on hemodynamic and/or gas exchange abnormalities : 1. Inability to maintain adequate hemodynamics and stable perfusion despite volume resuscitation and vasopressor administration and in the absence of readily correctable cause 2. Inability to tolerate pulmonary artery clamping 3. Inadequ

Первичные конечные точки

• ICU-free days [Срок оценки: From the end of surgery up to 28 days after surgery]

Вторичные конечные точки (12)

• Incidence and grade of primary graft dysfunction (PGD) at 0, 24, 48, and 72 hours [Срок оценки: From the end of surgery up to 72 hours after surgery]
• Incidence of all-cause mortality [Срок оценки: From the end of surgery to 90 days after surgery]
• Incidence of intraoperative blood product transfusion requirements [Срок оценки: Beginning from the surgical incision up to the arrival to the intensive care unit immediately after surgery]
• Incidence of perioperative blood product transfusion [Срок оценки: From the beginning of surgery up to 72 hours after surgery.]
• Intensive care unit and hospital length of stay in days [Срок оценки: Beginning from the arrival to the intensive care unit immediately after surgery]
• Incidence of re-intubation after surgery [Срок оценки: From the end of surgery until 28 days after surgery]
• Acute kidney injury (AKI) [Срок оценки: From the end of surgery up to 28 days after surgery]
• The composite incidence of death, disabling stroke, grade 2 or 3 PGD at 72 hours, major bleeding, vascular complications, or stage II or III acute kidney injury [Срок оценки: From the end of surgery up to 3, 14, 28 and 90 days.]
• Average financial costs and sustainability metrics [Срок оценки: From the beginning of surgery until 28 days after surgery]
• Incidence of postoperative stroke / cerebrovascular accident [Срок оценки: From the end of surgery up to 28 days after surgery]
• Incidence of postoperative bleeding complications [Срок оценки: From the end of surgery up to 28 days after surgery]
• Duration of mechanical ventilation in hours [Срок оценки: Beginning from the arrival to the intensive care unit immediately after surgery]

Критерии участия

Критерии включения

• Patients undergoing lung transplant surgery

Критерии исключения

• Inability to provide consent for the study
• Retransplantation
• Multi-organ transplantation
• Contra-indication to standard heparin anticoagulation (e.g., heparin-induced thrombocytopenia)
• Lung transplant recipients where intraoperative cardiopulmonary support is mandatory:
• Severe pulmonary hypertension (PH):

• Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
• Mean PAP ≥ 55 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
• The ratio of mean pulmonary to systemic artery pressure of \> 0.66
• Moderate to severe right ventricular (RV) hypokinesis or dysfunction
• Left ventricular dysfunction: Defined as ejection fraction (LVEF) less than 45% on echocardiography, ventriculography, computed tomography (CT), or magnetic resonance imaging (MRI)
• Patients requiring concomitant cardiac surgery: For example, significant coronary artery disease (CAD) requiring surgical grafting

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

Лечение

Центры проведения

Канада · 4 центра

• Univeristy of Alberta & Alberta Health Services — Edmonton
• Vancouver General Hospital — Vancouver
• University Health Network / Toronto General Hospiatl — Toronto
• Centre Hospitalier de l'Universite de Montreal — Montreal

Публикации

• Nasir BS, Weatherald J, Ramsay T, Cypel M, Donahoe L, Durkin C, Schisler T, Nagendran J, Liberman M, Landry C, Overbeek C, Moore A, Ferraro P. Randomized trial of routine versus on-demand intraoperative extracorporeal membrane oxygenation in lung transplantation: A feasibility study. J Heart Lung Transplant. 2024 Jun;43(6):1005-1009. doi: 10.1016/j.healun.2024.02.1454. Epub 2024 Feb 28. PMID 38423414

Идентификаторы

NCT: NCT06615492 · 2024-11391

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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