Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT01306903
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2011-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020374', 'term': 'Chromatography, Micellar Electrokinetic Capillary'}], 'ancestors': [{'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-03', 'studyFirstSubmitDate': '2011-03-01', 'studyFirstSubmitQcDate': '2011-03-01', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bloodloss', 'timeFrame': 'postoperative', 'description': 'Count of red blood packages'}]}, 'conditionsModule': {'keywords': ['Minimizing Cardiopulmonary Bypass MECC damage organ failure'], 'conditions': ['Postoperative Bloodloss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.kgu.de/index.php?id=3615', 'label': 'Research THG'}]}, 'descriptionModule': {'briefSummary': 'The standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation.\n\nThe aim of this study is the evaluation of potential differences between a minimal extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* extracorporeal circulation\n* age \\> 18 years old'}, 'identificationModule': {'nctId': 'NCT01306903', 'acronym': 'MECC', 'briefTitle': 'Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures', 'orgStudyIdInfo': {'id': 'Mini-ECC001AHK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MECC', 'description': 'Minimal extracorporeal circuit', 'interventionNames': ['Device: MECC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MOPS', 'interventionNames': ['Device: MOPS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Super MOPS', 'interventionNames': ['Device: Super MOPS']}], 'interventions': [{'name': 'MECC', 'type': 'DEVICE', 'description': 'Minimized extracorporeal circulation', 'armGroupLabels': ['MECC']}, {'name': 'MOPS', 'type': 'DEVICE', 'description': 'Modified and optimized perfusion system Frankfurt', 'armGroupLabels': ['MOPS']}, {'name': 'Super MOPS', 'type': 'DEVICE', 'description': 'Super modified and optimized perfusion system Frankfurt', 'armGroupLabels': ['Super MOPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Arndt H Kiessling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University Frankfurt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Arndt-H. Kiessling', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}