Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-31 @ 8:09 PM
Study NCT ID:
NCT00821158
Status:
UNKNOWN
Last Update Posted:
2009-01-13
First Post:
2009-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000975', 'term': 'Antioxidants'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-01-12', 'studyFirstSubmitDate': '2009-01-12', 'studyFirstSubmitQcDate': '2009-01-12', 'lastUpdatePostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antioxidant concentrations', 'timeFrame': '0,5-24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemia-Reperfusion']}, 'descriptionModule': {'briefSummary': 'The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing breast reconstruction\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Kidney or liver disease\n* Use of immunosuppressants'}, 'identificationModule': {'nctId': 'NCT00821158', 'briefTitle': 'The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study', 'orgStudyIdInfo': {'id': 'MEC 25-11-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo tablet and iv', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Placebo tablet and intervention iv', 'interventionNames': ['Drug: Antioxidant']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Intervention tablet and placebo iv', 'interventionNames': ['Drug: Anti-inflammatory drug']}], 'interventions': [{'name': 'Antioxidant', 'type': 'DRUG', 'description': 'Antioxidant iv bolus', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo tablet and iv', 'armGroupLabels': ['1']}, {'name': 'Anti-inflammatory drug', 'type': 'DRUG', 'description': 'Anti-inflammatory tablet', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O. Box 5800, 6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'contacts': [{'name': 'Marieke van den Heuvel, M.D.', 'role': 'CONTACT', 'email': 'm.vandenheuvel@ah.unimaas.nl', 'phone': '0031-43-3875496'}, {'name': 'Marieke van den Heuvel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Marieke van den Heuvel, M.D.', 'role': 'CONTACT', 'email': 'm.vandenheuvel@ah.unimaas.nl', 'phone': '0031-43-3875496'}, {'name': 'R. van der Hulst, M.D., Phd', 'role': 'CONTACT', 'email': 'r.vander.hulst@mumc.nl', 'phone': '0031-43-3877481'}], 'overallOfficials': [{'name': 'R. van der Hulst, M.D., Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Maastricht Universtity Medical Center'}, {'name': 'Marieke van den Heuvel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'R. van der Hulst, M.D., Phd', 'oldOrganization': 'Maastricht University Medical Center'}}}}