Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
Study NCT ID:
NCT06615492
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-09-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Routine vs On-demand ECMO for Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-24', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU-free days', 'timeFrame': 'From the end of surgery up to 28 days after surgery', 'description': 'Intensive care unit (ICU)-free days in the first 28 days post-lung transplant (28 minus the ICU length of stay)'}], 'secondaryOutcomes': [{'measure': 'Incidence and grade of primary graft dysfunction (PGD) at 0, 24, 48, and 72 hours', 'timeFrame': 'From the end of surgery up to 72 hours after surgery', 'description': 'The definition is based on the criteria for the International Society of Heart and Lung Transplantation (ISHLT) grading system.'}, {'measure': 'Incidence of all-cause mortality', 'timeFrame': 'From the end of surgery to 90 days after surgery', 'description': 'Death, whatever the cause'}, {'measure': 'Incidence of intraoperative blood product transfusion requirements', 'timeFrame': 'Beginning from the surgical incision up to the arrival to the intensive care unit immediately after surgery', 'description': 'Number of packed red blood cell units and total blood product units (red blood cells, plasma, platelets, prothrombin complex concentrates) transfused.'}, {'measure': 'Incidence of perioperative blood product transfusion', 'timeFrame': 'From the beginning of surgery up to 72 hours after surgery.', 'description': 'Number of packed red blood cell units and total blood product units (red blood cells, plasma, platelets, prothrombin complex concentrates) transfused.'}, {'measure': 'Intensive care unit and hospital length of stay in days', 'timeFrame': 'Beginning from the arrival to the intensive care unit immediately after surgery', 'description': 'Lenght of stay in the intensive care and in the hospital'}, {'measure': 'Incidence of re-intubation after surgery', 'timeFrame': 'From the end of surgery until 28 days after surgery', 'description': 'Need to reintubate after extubation after surgery'}, {'measure': 'Acute kidney injury (AKI)', 'timeFrame': 'From the end of surgery up to 28 days after surgery', 'description': 'The definition of AKI is based on Kidney Disease; improving global outcomes (KDIGO) classification'}, {'measure': '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', 'timeFrame': 'From the end of surgery up to 3, 14, 28 and 90 days.', 'description': 'Composite outcome of potential complications related to routine and on-demand ECMO'}, {'measure': 'Average financial costs and sustainability metrics', 'timeFrame': 'From the beginning of surgery until 28 days after surgery', 'description': 'The average dollar costs and waste in kg per patient related to the use of ECMO, including perfusionist labour and all materials.'}, {'measure': 'Incidence of postoperative stroke / cerebrovascular accident', 'timeFrame': 'From the end of surgery up to 28 days after surgery', 'description': 'Stroke, disabling stroke or non-disabling stroke.\n\n1. Stroke: Duration of a focal or global neurological deficit ≥ 24 hours; OR \\< 24 hours if neuroimaging shows a new hemorrhage or infarct; OR the neurological deficit results in death\n2. Disabling stroke: A modified Rankin Score (mRS) of ≥ 2 at three days OR an increase in at least one mRS category from baseline for individuals with a pre-stroke baseline ≥ 1 16,17.\n3. Non-disabling stroke: An mRS score of \\< 2 at 14 days or one that does not increase in at least one mRS category from an individuals pre-stroke baseline'}, {'measure': 'Incidence of postoperative bleeding complications', 'timeFrame': 'From the end of surgery up to 28 days after surgery', 'description': 'The definition of bleeding complication is based on Bleeding Academic Research Consortium (BARC) classification. Bleeding is defined as Major or Minor.'}, {'measure': 'Duration of mechanical ventilation in hours', 'timeFrame': 'Beginning from the arrival to the intensive care unit immediately after surgery', 'description': 'BiPAP and CPAP are not considered mechanical ventilation. Tracheostomy is not considered mechanical ventilation if a ventilator is not needed.'}, {'measure': 'Incidence of postoperative tracheostomy', 'timeFrame': 'From the end of surgery until 28 days after surgery', 'description': 'Need for a tracheostomy after surgery in a patient without a previous tracheostomy'}, {'measure': 'Incidence of vascular complications', 'timeFrame': 'From the end of surgery to 28 days after surgery', 'description': 'Major or minor vascular complications (see protocol)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'Lung Transplantation'], 'conditions': ['Respiratory Failure', 'Interstitial Lung Disease (ILD)', 'Pulmonary Fibrosis', 'COPD (Chronic Obstructive Pulmonary Disease)']}, 'referencesModule': {'references': [{'pmid': '38423414', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nAlthough 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.\n\nTherefore, 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing lung transplant surgery\n\nExclusion Criteria:\n\n* Inability to provide consent for the study\n* Retransplantation\n* Multi-organ transplantation\n* Contra-indication to standard heparin anticoagulation (e.g., heparin-induced thrombocytopenia)\n* Lung transplant recipients where intraoperative cardiopulmonary support is mandatory:\n* Severe pulmonary hypertension (PH):\n\n 1. Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement\n 2. Mean PAP ≥ 55 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement\n 3. The ratio of mean pulmonary to systemic artery pressure of \\> 0.66\n* Moderate to severe right ventricular (RV) hypokinesis or dysfunction\n* Left ventricular dysfunction: Defined as ejection fraction (LVEF) less than 45% on echocardiography, ventriculography, computed tomography (CT), or magnetic resonance imaging (MRI)\n* Patients requiring concomitant cardiac surgery: For example, significant coronary artery disease (CAD) requiring surgical grafting'}, 'identificationModule': {'nctId': 'NCT06615492', 'acronym': 'REVOLUTION', 'briefTitle': 'Routine vs On-demand ECMO for Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'RoutinE Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation (ECMO) During LUng TransplantatION (REVOLUTION)', 'orgStudyIdInfo': {'id': '2024-11391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Routine ECMO', 'description': 'Routine ECMO during lung tansplant', 'interventionNames': ['Device: Routine ECMO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'On-demand ECMO', 'description': 'Selective, indication-based intraoperative cardiopulmonary support.', 'interventionNames': ['Device: On-demand ECMO']}], 'interventions': [{'name': 'Routine ECMO', 'type': 'DEVICE', 'description': 'Routine intraoperative venoarterial ECMO during lung transplant', 'armGroupLabels': ['Routine ECMO']}, {'name': 'On-demand ECMO', 'type': 'DEVICE', 'description': '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 :\n\n1. Inability to maintain adequate hemodynamics and stable perfusion despite volume resuscitation and vasopressor administration and in the absence of readily correctable cause\n2. Inability to tolerate pulmonary artery clamping\n3. Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching\n4. Inadequate exposure to the surgical field\n5. The transplant team is concerned about the ability to maintain organ perfusion or ventilate with a lung protective strategy, even if the aforementioned criteria are unmet.\n6. Concerns about donor lung quality and a desire to protect the implanted lung from single lung perfusion', 'armGroupLabels': ['On-demand ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G2G3', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jason Weatherald, MD, MSc', 'role': 'CONTACT', 'email': 'weathera@ualberta.ca', 'phone': '780 492 9937'}, {'name': 'Jayan Nagendran, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Univeristy of Alberta & Alberta Health Services', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Vancouver', 'state': 'British Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Christopher Durkin, MD', 'role': 'CONTACT', 'email': 'Christopher.durkin@vch.ca', 'phone': '604 875-4111'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 1M1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marcelo Cypel, MD, MSc', 'role': 'CONTACT', 'email': 'marcelo.cypel@uhn.ca', 'phone': '4163404800'}, {'name': 'Laura Donahoe, MD, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Health Network / Toronto General Hospiatl', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X3E4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Basil Nasir, MD', 'role': 'CONTACT', 'email': 'basilsnasir@gmail.com', 'phone': '514-890-8000', 'phoneExt': '24543'}, {'name': 'Alex Moore, MD', 'role': 'CONTACT', 'email': 'alex.moore@umontreal.ca', 'phone': '514-890-8000', 'phoneExt': '12171'}, {'name': 'Caroline Landry, CCP, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Basil Nasir, MD', 'role': 'CONTACT', 'email': 'basilsnasir@gmail.com', 'phone': '514-890-8000', 'phoneExt': '24543'}, {'name': 'Alex Moore, MD', 'role': 'CONTACT', 'email': 'alex.moore@umontreal.ca', 'phone': '514-890-8000', 'phoneExt': '12171'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}