Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-26 @ 8:23 PM
Study NCT ID:
NCT01834092
Status:
UNKNOWN
Last Update Posted:
2013-04-17
First Post:
2013-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Glycocalyx in Abdominal Aortic Aneurysm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-16', 'studyFirstSubmitDate': '2013-04-13', 'studyFirstSubmitQcDate': '2013-04-16', 'lastUpdatePostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative organ failure', 'timeFrame': '30 days', 'description': 'Development of kidney- and respiratory failure and sepsis'}], 'primaryOutcomes': [{'measure': 'Endothelial dysfunction', 'timeFrame': '24 hours', 'description': 'Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1'}], 'secondaryOutcomes': [{'measure': 'Fluid balance', 'timeFrame': '24 hours', 'description': 'Perioperative and postoperative first 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abdominal Aortic Aneurism', 'Endothelia', 'Glycocalyx', 'Reperfusion', 'Plasma'], 'conditions': ['Abdominal Aortic Aneurism', 'Surgery', 'Ischemic Reperfusion Injury']}, 'descriptionModule': {'briefSummary': 'The investigators want to measure the degradation of the endothelial glycocalyx before and after clamping the aorta, in patients operated for a abdominal aortic aneurism.', 'detailedDescription': '50 patients is scheduled for enrollment. Blood samples will be up taken before surgery, 10 min after reperfusion, at the end of surgery and the following morning. In addition the investigators are placing a renal venous catheter where blood samples will be up taken as mentioned above for the analysis of endothelial markers together with markers for kidney damage.\n\nThe first 10 patient will act as part of a pilot study, where only measurement of the endothelial and renal failure markers will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 18 years\n\nExclusion Criteria:\n\n* prior engagement in scientific study within the last 30 days.'}, 'identificationModule': {'nctId': 'NCT01834092', 'acronym': 'Endo_eAAA', 'briefTitle': 'Study of the Glycocalyx in Abdominal Aortic Aneurysm', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.', 'orgStudyIdInfo': {'id': 'H-4-2012-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fresh frozen plasma', 'description': '2 portions of FFP will be transfused prior to reperfusion', 'interventionNames': ['Other: Plasma']}, {'type': 'EXPERIMENTAL', 'label': 'Fresh non-frozen plasma', 'description': '2 portions of non-frozen plasma will be transfused prior to reperfusion', 'interventionNames': ['Other: Plasma']}], 'interventions': [{'name': 'Plasma', 'type': 'OTHER', 'otherNames': ['Fresh frozen plasma versus fresh non-frozen plasma'], 'description': '2 Units of plasma transfused equvilant to 2 times 275ml', 'armGroupLabels': ['Fresh frozen plasma', 'Fresh non-frozen plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Copenhagen', 'state': 'Østerbro', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Thomas B Jørgensen, MD', 'role': 'CONTACT', 'email': 'thomas.bech.aaa@gmail.com', 'phone': '+4535458734'}, {'name': 'Thomas B Jørgensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Thomas B Jørgensen, MD', 'role': 'CONTACT', 'email': 'thomas.bech.aaa@gmail.com', 'phone': '+4535458734'}], 'overallOfficials': [{'name': 'Per I Johansson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Thomas Bech Jorgensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}