Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-29 @ 3:59 PM
Study NCT ID:
NCT01345968
Status:
TERMINATED
Last Update Posted:
2013-08-09
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Less patients than expected for inclusion, therefore recruitment is too low', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of RBC units', 'timeFrame': 'Until postoperative day 7'}], 'secondaryOutcomes': [{'measure': 'Blood transfusion rate', 'timeFrame': 'Until postoperative day 7', 'description': 'Number of patients with blood transfusions'}, {'measure': 'Frequency of postoperative complications', 'timeFrame': 'Until postoperative day 7', 'description': 'Number of postoperative complications from baseline until postoperative day 7'}, {'measure': 'Frequency of postoperative complications', 'timeFrame': 'Until 6 weeks after surgical intervention', 'description': 'Number of postoperative complication from baseline until 6 weeks after surgical intervention'}, {'measure': 'Length of hospital stay', 'timeFrame': '6 weeks after surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anemia', 'transfusion', 'intravenous ferric carboxymaltose'], 'conditions': ['Anemia', 'Orthopedic Surgery', 'High Risk of Blood Loss']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 18 years\n* Patients scheduled to undergo hip or knee replacement\n* 8 g/dl \\< Hb \\< 13 g/dl for men and 8 g/dl \\< Hb \\< 12 g/dl for women at screening (3-4 weeks prior to surgery)\n* anemia\n* signed written informed consent\n\nExclusion Criteria:\n\n* immunosuppressive or myelosuppressive therapy\n* history of thromboembolic events\n* a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient\n* hypersensitivity to any component of the formulation\n* transfusion within 1 month prior to study inclusion\n* liver values 3 times higher than normal\n* active severe infection/inflammation\n* renal insufficiency'}, 'identificationModule': {'nctId': 'NCT01345968', 'acronym': 'PRIVIRON', 'briefTitle': 'Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss', 'orgStudyIdInfo': {'id': 'UKM10_0027'}, 'secondaryIdInfos': [{'id': '2010-024115-14', 'type': 'EUDRACT_NUMBER'}, {'id': '05-AnIt-09', 'type': 'OTHER', 'domain': 'Department of Anesthesiology and Intensive Care, University Hospital Muenster'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl 0.9%', 'interventionNames': ['Drug: NaCl 0.9%']}, {'type': 'EXPERIMENTAL', 'label': 'Ferinject', 'interventionNames': ['Drug: Ferinject 50 mg/ml']}], 'interventions': [{'name': 'Ferinject 50 mg/ml', 'type': 'DRUG', 'description': 'iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes', 'armGroupLabels': ['Ferinject']}, {'name': 'NaCl 0.9%', 'type': 'DRUG', 'description': 'iv administration of max. 50 ml in 30 minutes', 'armGroupLabels': ['NaCl 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Hugo K Van Aken, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia and Intensiv Care, University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vifor Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}