Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-12 @ 6:15 AM
Study NCT ID:
NCT03508505
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2018-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002303', 'term': 'Cardiac Output, Low'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015199', 'term': 'Extracorporeal Membrane Oxygenation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D001026', 'term': 'Coronary Artery Bypass'}, {'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}, {'id': 'D058386', 'term': 'Mitral Valve Annuloplasty'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D058385', 'term': 'Cardiac Valve Annuloplasty'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2018-03-06', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital death', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'All-cause death'}], 'secondaryOutcomes': [{'measure': 'Late death', 'timeFrame': 'Up to 7-year follow-up after the index cardiac surgery', 'description': 'All-cause death'}, {'measure': 'Stroke', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Ischemic infarction or hemorrhagic injury of the brain'}, {'measure': 'Tracheostomy', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Respiratory failure requiring tracheostomy'}, {'measure': 'Gastrointestinal complications', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Gastrointestinal complications requiring surgical treatment'}, {'measure': 'Deep sternal wound infection', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Deep sternal wound infection or mediastinitis'}, {'measure': 'Vascular access site infection', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Infection secondary to any vascular access'}, {'measure': 'Blood stream infection', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Blood stream infection detected at blood cultures'}, {'measure': 'Peripheral vascular injury', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Any aortic and/or peripheral artery complications related to VA-ECMO'}, {'measure': 'Major lower limb amputation', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Major lower limb amputation'}, {'measure': 'New onset dialysis', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'New onset dialysis'}, {'measure': 'Peak postoperative serum creatinine level', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Peak postoperative serum creatinine level'}, {'measure': 'Nadir postoperative pH during VA-ECMO', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Nadir postoperative pH during VA-ECMO'}, {'measure': 'Peak postoperative arterial lactate level', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Peak postoperative arterial lactate level'}, {'measure': 'Nadir postoperative hemoglobin level', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Nadir postoperative hemoglobin level'}, {'measure': 'Chest drainage output 24 h after surgery', 'timeFrame': 'Up to 24 hours after the index cardiac surgery', 'description': 'Chest drainage output 24 h after surgery'}, {'measure': 'Number of red blood cells units transfused intra- and postoperatively', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Number of red blood cells units transfused intra- and postoperatively'}, {'measure': 'Reoperation for intrathoracic bleeding', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Reoperation for intrathoracic bleeding'}, {'measure': 'Reoperation for peripheral cannulation-related bleeding', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Reoperation for peripheral cannulation-related bleeding'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Intensive care unit length of stay'}, {'measure': 'Death on VA-ECMO', 'timeFrame': 'Up to 30 days after the index cardiac surgery', 'description': 'Death on VA-ECMO'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Heart Failure', 'Low Output Heart Failure', 'Cardiac Low Output', 'Extracorporeal Membrane Oxygenation', 'ECMO', 'Venoarterial Extracorporeal membrane oxygenation', 'Cardiac Surgery'], 'conditions': ['Acute Heart Failure', 'Low Output Heart Failure', 'Cardiac Output, Low', 'Extracorporeal Membrane Oxygenation', 'Cardiac Surgery', 'Venoarterial Extracorporeal Membrane Oxygenation']}, 'referencesModule': {'references': [{'pmid': '33580776', 'type': 'DERIVED', 'citation': "Biancari F, Perrotti A, Ruggieri VG, Mariscalco G, Dalen M, Dell'Aquila AM, Jonsson K, Ragnarsson S, Di Perna D, Bounader K, Gatti G, Juvonen T, Alkhamees K, Yusuff H, Loforte A, Lechiancole A, Chocron S, Pol M, Spadaccio C, Pettinari M, De Keyzer D, Fiore A, Welp H. Five-year survival after post-cardiotomy veno-arterial extracorporeal membrane oxygenation. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):595-601. doi: 10.1093/ehjacc/zuaa039."}, {'pmid': '32305219', 'type': 'DERIVED', 'citation': "Mariscalco G, Fiore A, Ragnarsson S, El-Dean Z, Jonsson K, Dalen M, Fux T, Ruggieri VG, Gatti G, Juvonen T, Zipfel S, Dell'Aquila AM, Perrotti A, Bounader K, Settembre N, Loforte A, Livi U, Pol M, Spadaccio C, Pettinari M, Reichart D, Alkhamees K, Welp H, Maselli D, Lichtenberg A, Biancari F; PC-ECMO group. Venoarterial Extracorporeal Membrane Oxygenation After Surgical Repair of Type A Aortic Dissection. Am J Cardiol. 2020 Jun 15;125(12):1901-1905. doi: 10.1016/j.amjcard.2020.03.012. Epub 2020 Mar 31."}]}, 'descriptionModule': {'briefSummary': 'Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.\n\nData on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous patient populations, which prevent conclusive results on the benefits of VA-ECMO in this setting. This issue will be investigated in the present retrospective European multicenter study.\n\nIn this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.\n\nData on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous populations of patients who underwent different cardiac procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and this does not provide an exact measure of the benefits of this treatment strategy.\n\nThe possible benefits of using VA-ECMO after adult cardiac surgery will be investigated in this retrospective European multicenter study.', 'detailedDescription': 'Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Prolonged aortic cross-clamping, ischemia-reperfusion injury, suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.\n\nData on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous and small size series of patients who underwent different cardiac surgery procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and, in view of the development of perfusion technology and perioperative care, this does not provide an exact measure of the current benefits of this treatment strategy. Importantly, the role of intra-aortic balloon pump, left ventricular venting, duration of VA-ECMO and hospital experience should be evaluated. The investigators sought to investigate these issues in a large multicenter study.\n\nPatients and methods Patients who were treated with VA-ECMO for cardiac low-output after adult cardiac surgery (other than heart transplantation and/or implantation of a left ventricular assist device) in 21 centers of cardiac surgery from January 2010 to December 2017.\n\nEligibility criteria\n\n* Patients aged \\> 18 years;\n* Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery because of postoperative low-cardiac output syndrome and/or acute respiratory failure.\n\nExclusion criteria\n\n* Patients aged \\< 18 years;\n* Any VA-ECMO implanted before index surgical procedure;\n* Patients who underwent postoperatively veno-venous ECMO;\n* Patients who required VA-ECMO after heart transplantation;\n* Patients who required VA-ECMO after any left ventricular assist device.\n\nDefinition criteria Definition criteria and units of measurements are reported beside each baseline, operative and postoperative variables in the electronic datasheet.\n\nOutcomes\n\n1. Hospital death\n2. Late death\n3. Stroke\n4. Tracheostomy\n5. Gastrointestinal complications\n6. Deep sternal wound infection\n7. Vascular access site infection\n8. Blood stream infection\n9. Peripheral vascular injury\n10. Major lower limb amputation\n11. New onset dialysis\n12. Peak postoperative serum creatinine level\n13. Nadir postoperative pH during VA-ECMO\n14. Peak postoperative arterial lactate level\n15. Nadir postoperative hemoglobin level\n16. Chest drainage output 24 h after surgery\n17. Number of red blood cells units transfused intra- and postoperatively\n18. Reoperation for intrathoracic bleeding\n19. Reoperation for peripheral cannulation-related bleeding\n20. Intensive care unit length of stay\n21. Death on VA-ECMO\n\nAnalysis of clinical results\n\nThe aim of this registry is to perform a number of analysis evaluating:\n\n1. Early and late survival of postcardiotomy VA-ECMO;\n2. Predictors and causes of in-hospital death after successful weaning from postcardiotomy VA-ECMO;\n3. Comparative analysis of peripheral versus central postcardiotomy VA-ECMO;\n4. VA-ECMO plus intra-aortic baloon pump vs. isolated VA-ECMO;\n5. Determinants of outcome after prolonged postcardiotomy VA-ECMO (\\>5 days).\n\nPublication of results The results of these studies will be submitted for publication to international, peer-reviewed journals in the fields of critical care, cardiology or cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who required VA-ECMO for acute heart failure occurring during the index hopsitalization for elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.\n\nExclusion Criteria:\n\n* Any VA-ECMO implanted before index surgical procedure;\n* Patients who underwent postoperatively veno-venous ECMO;\n* Patients who required VA-ECMO after heart transplantation;\n* Patients who required VA-ECMO after any left ventricular assist device.'}, 'identificationModule': {'nctId': 'NCT03508505', 'acronym': 'PC-ECMO', 'briefTitle': 'Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation', 'orgStudyIdInfo': {'id': 'T3/2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Venoarterial extracorporeal oxygenation', 'type': 'DEVICE', 'otherNames': ['Cardiac surgery', 'Coronary artery bypass grafting', 'Aortic valve replacement', 'Mitral valve repair', 'Aortic surgery'], 'description': 'Veno-arterial extracorporeal oxygenation (VA-ECMO) is inserted in the acute setting in case of cardiac low output after adult cardiac surgery in order to provide cardiopulmonary support to recovery or as bridge to transplantation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Heart Center, Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Upon request, the investigators will ask the Ethical Committee of the participating centers for permission to share all individual participant data included in this registry with the exception of data through which the patients could be identified.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Ospedali Riuniti Trieste', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'University of Burgundy', 'class': 'OTHER'}, {'name': 'CHU de Reims', 'class': 'OTHER'}, {'name': 'Rennes University Hospital', 'class': 'OTHER'}, {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, {'name': 'Glenfield Hospital', 'class': 'OTHER'}, {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, {'name': 'University Hospital Muenster', 'class': 'OTHER'}, {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'University Hospital, Udine, Italy', 'class': 'OTHER'}, {'name': 'Golden Jubilee National Hospital', 'class': 'OTHER_GOV'}, {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Helios Research Center', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Lund University Hospital', 'class': 'OTHER'}, {'name': 'Prince Sultan Cardiac Center, Adult Cardiology Department.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}