Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-26 @ 9:49 AM
Study NCT ID:
NCT02020759
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Microemboli in Venoarterial ECMO Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-12-24', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral embolic load', 'timeFrame': '30 minutes', 'description': 'Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Complication of Extracorporeal Membrane Oxygenation', 'Cerebral Microembolism', 'Cerebral Perfusion']}, 'referencesModule': {'references': [{'pmid': '34406372', 'type': 'DERIVED', 'citation': 'Kietaibl C, Horvat Menih I, Engel A, Ullrich R, Klein KU, Erdoes G. Cerebral microemboli during extracorporeal life support: a single-centre cohort study. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):172-179. doi: 10.1093/ejcts/ezab353.'}]}, 'descriptionModule': {'briefSummary': 'Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes.\n\nIn venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated ME are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. Although patient exposure to cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral ME in patients undergoing ECMO therapy.\n\nThe primary study goal of this study is to determine the load and nature of cerebral ME in critically ill patients under va-ECMO support. We also aim to compare the results to measurements in healthy subjects und intensive care unit (ICU) patients without extracorporeal support to get a better impression on the relevance of ME generation during ECMO support.', 'detailedDescription': 'The addition of ICU patients was made according to reviewer suggestions after an initial submission to a medical journal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of three patient groups with all receiving transcranial Doppler exam: 1. patients undergoing ECMO therapy in the ICU; 2. healthy volunteers, and 3. critically ill controls (patients on the ICU without ECMO)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (for patients):\n\n* Intensive care patients with cardiac or respiratory failure under va-ECMO therapy\n* Age \\> 18 yrs.\n* Signed informed consent\n\nExclusion Criteria:\n\n* use of any other extracorporeal device including venovenous (vv) ECMO\n* continuous renal replacement therapy\n* medical history of severe mitral or aortic stenosis\n* medical history of severe mitral or aortic regurgitation\n* medical history of carotid stenosis \\> 70 %\n* septicaemia\n* medical history of vascular dementia or Alzheimer's disease\n* inclusion in an other clinical study\n* gravidity\n* allergy against materials of one of the medical device used in the study"}, 'identificationModule': {'nctId': 'NCT02020759', 'briefTitle': 'Cerebral Microemboli in Venoarterial ECMO Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation', 'orgStudyIdInfo': {'id': '1557/2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient on ECMO', 'description': 'Neurological monitoring with transcranial Doppler ultrasound', 'interventionNames': ['Device: Transcranial Doppler Ultrasound']}, {'label': 'Healthy subjects', 'description': 'Neurological monitoring with transcranial Doppler ultrasound', 'interventionNames': ['Device: Transcranial Doppler Ultrasound']}, {'label': 'ICU patients', 'description': 'Neurological monitoring with transcranial Doppler ultrasound', 'interventionNames': ['Device: Transcranial Doppler Ultrasound']}], 'interventions': [{'name': 'Transcranial Doppler Ultrasound', 'type': 'DEVICE', 'description': 'Transcranial Doppler Ultrasound is used to monitor cerebral microembolism', 'armGroupLabels': ['Healthy subjects', 'ICU patients', 'Patient on ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gabor Erdoes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Gabor Erdoes', 'investigatorFullName': 'Dr. Gabor Erdoes', 'investigatorAffiliation': 'Medical University of Vienna'}}}}