Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT03642912
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2018-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation (Observational Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2018-08-11', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'bleeding assessment', 'timeFrame': 'after starting ECMO therapy - up to 28 days after starting ECMO therapy', 'description': 'all patients are screened for signs of bleeding or thrombosis'}, {'measure': 'bleeding assessment', 'timeFrame': 'one week after ending ECMO therapy', 'description': 'all patients are screened for signs of bleeding or thrombosis'}], 'primaryOutcomes': [{'measure': 'platelet function parameter', 'timeFrame': 'after starting ECMO therapy - up to 28 days after starting ECMO therapy', 'description': 'platelet function test'}, {'measure': 'platelet function parameter', 'timeFrame': 'one week after ending ECMO therapy', 'description': 'platelet function test'}, {'measure': 'coagulation parameter', 'timeFrame': 'after starting ECMO therapy - up to 28 days after starting ECMO therapy', 'description': 'thromboelastometric test'}, {'measure': 'coagulation parameter', 'timeFrame': 'one week after ending ECMO therapy', 'description': 'thromboelastometric test'}], 'secondaryOutcomes': [{'measure': 'inflammatory parameter', 'timeFrame': 'after starting ECMO therapy - up to 28 days after starting ECMO therapy', 'description': 'bradykinin levels'}, {'measure': 'inflammatory parameter', 'timeFrame': 'one week after ending ECMO therapy', 'description': 'bradykinin levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'haemostasis', 'coagulation', 'haemostatic alterations'], 'conditions': ['Coagulation and Hemorrhagic Disorders', 'Extracorporeal Membrane Oxygenation Complication']}, 'descriptionModule': {'briefSummary': 'Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich.', 'detailedDescription': 'Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich. Adult ECMO patients are included in the study after informed consent.\n\nBleeding and thromboembolic complications as well as treatment details are recorded. Additional coagulation laboratory markers (such as von-Willebrand-factor, ADAMTS13-protease, platelet function tests and thromboelastometric tests) are correlated with clinical signs of bleeding. Regular ultrasound examination of the large vessels are performed to Screen for thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'critically ill patients treated with ECMO', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient treated on ICU of Department of Anesthesiology of LMU Munich\n* treated with ECMO\n* age \\>/= 18 years (adult patients only)\n* informed consent\n\nExclusion Criteria:\n\n* underage patients\n* pregnant patients\n* hemoglobin level \\< 8mg/dl'}, 'identificationModule': {'nctId': 'NCT03642912', 'briefTitle': 'Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation (Observational Study)', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation Hämostaseologisches Monitoring Bei Patienten Mit Extrakorporaler Membranoxygenierung', 'orgStudyIdInfo': {'id': 'LMU 18-047'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO patients', 'description': 'ECMO patients treated on the intensive care units of the Department of Anesthesiology of LMU Munich'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Department of Anesthesiology, LMU Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Michael Zoller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology, LMU Munich'}, {'name': 'Mathias Bruegel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Laboratory Medicine, LMU Munich'}, {'name': 'Dominik J Hoechter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology, LMU Munich'}, {'name': 'Michael Weigand, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Laboratory Medicine, LMU Munich'}, {'name': 'Bernhard Zwißler, MD, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology, LMU Munich'}, {'name': 'Daniel Teupser, MD, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Laboratory Medicine, LMU Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Zoller MD', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}