Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT01180894
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2010-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IV Iron for the Anemia of Traumatic Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fredric.pieracci@dhha.org', 'phone': '303-436-4029', 'title': 'Dr. Fredric Pieracci', 'organization': 'Denver Health Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Iron Sucrose', 'description': '100 mg IV TIW\n\nIron sucrose: 100 mg IV TIW', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\n100 mg Normal saline', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Mortality', 'notes': 'In hospital mortality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'RBC Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Sucrose', 'description': '100 mg IV TIW\n\nIron sucrose: 100 mg IV TIW'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pacebo - Normal Saline\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '42 Days', 'description': 'The number of participants who underwent RBC transfusion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Iron-deficient Erythropoeisis (IDE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Sucrose', 'description': '100 mg IV TIW\n\nIron sucrose: 100 mg IV TIW'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\n100 mg Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '344'}, {'value': '118', 'groupId': 'OG001', 'lowerLimit': '78', 'upperLimit': '244'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.', 'unitOfMeasure': 'micro mol: mol heme', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Sucrose', 'description': '100 mg IV TIW\n\nIron sucrose: 100 mg IV TIW'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (100 mg normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 Days', 'description': 'The number of participants with at least one infection.\n\nSpecific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Sucrose', 'description': '100 mg IV TIW\n\nIron sucrose: 100 mg IV TIW'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (100 mg normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 Days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Iron Sucrose', 'description': '100 mg IV TIW\n\nIron sucrose: 100 mg IV TIW'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (100 mg normal saline)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Iron Sucrose', 'description': '100 mg IV TIW\n\nIron sucrose: 100 mg IV TIW'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\n100 mg Normal saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '83'}, {'value': '40.4', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '87'}, {'value': '41.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-10', 'studyFirstSubmitDate': '2010-08-11', 'resultsFirstSubmitDate': '2015-09-16', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-23', 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RBC Transfusion', 'timeFrame': '42 Days', 'description': 'The number of participants who underwent RBC transfusion.'}], 'secondaryOutcomes': [{'measure': 'Iron-deficient Erythropoeisis (IDE)', 'timeFrame': '14 Days', 'description': 'An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.'}, {'measure': 'Infection', 'timeFrame': '28 Days', 'description': 'The number of participants with at least one infection.\n\nSpecific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI).'}, {'measure': 'The Number of Participants Who Died', 'timeFrame': '28 Days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Trauma', 'Anemia', 'Iron', 'Erythropoeisis'], 'conditions': ['Trauma', 'ICU Anemia']}, 'referencesModule': {'references': [{'pmid': '24797376', 'type': 'DERIVED', 'citation': 'Pieracci FM, Stovall RT, Jaouen B, Rodil M, Cappa A, Burlew CC, Holena DN, Maier R, Berry S, Jurkovich J, Moore EE. A multicenter, randomized clinical trial of IV iron supplementation for anemia of traumatic critical illness*. Crit Care Med. 2014 Sep;42(9):2048-57. doi: 10.1097/CCM.0000000000000408.'}], 'seeAlsoLinks': [{'url': 'http://www.nationaltraumainstitute.org/', 'label': 'National Trauma Institute'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to determine whether intravenous iron supplementation of anemic, critically ill trauma patients improves anemia and reduces the need for a red blood cell transfusion.', 'detailedDescription': 'Nearly all trauma patients admitted to an intensive care unit (ICU) are anemic (low red blood cell counts). Anemia is an independent risk factor for poor outcomes, including infection, impaired wound healing, and death. Current therapies for ICU anemia are unsatisfactory: Red blood cell (RBC) transfusion is associated with an increased risk of immune suppression, infection, and organ failure. Furthermore, use of both hemoglobin replacement products and erythropoietin are limited by expense as well as unfavorable side effect profiles.\n\nOne principal cause of anemia in trauma ICU patients involves disturbances in iron metabolism. Iron is necessary to make RBCs, and a lack of iron delivered to the bone marrow results in anemia. Trauma causes diversion of iron from the bone marrow into storage, where it cannot participate in the generation of RBCs. This diversion of iron is caused by inflammatory proteins released as a result of tissue injury.\n\nPrevious work by the principal investigator among ICU patients suggested a benefit to oral iron supplementation administered in dosages similar to those used in a standard multivitamin. However, many patients were not able to tolerate oral medications, and this study was not specific to trauma patients. Additional research has suggested that intravenous iron supplementation is effective in treating anemic patients with other inflammatory conditions, such as cancer and inflammatory bowel disease. However, the benefit of intravenous iron supplementation has never been tested among anemic ICU patients, including trauma patients.\n\nThe current clinical trial will evaluate the risk/benefit profile of intravenous iron supplementation among anemic trauma ICU patients. The study will take place over several academic trauma centers with a long history of participation in translational research.\n\nAnemia remains a devastating complication of trauma. Current treatment options are limited. Intravenous iron supplementation represents a targeted, cost-effective solution to this pervasive problem, the efficacy of which remains undefined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ICU admission for trauma\n* Adults (age ≥ 18 years)\n* Anemia (hemoglobin \\< 12 g/dL)\n* ≤ 72 hours from ICU admission\n* Expected ICU length of stay ≥ 7 days\n\nExclusion Criteria:\n\n* Active hemorrhage requiring RBC transfusion\n* Iron overload (serum ferritin concentration ≥ 1,000 ng/mL) or any condition associated with iron overload (e.g., hemochromatosis, aceruloplasminemia\n* Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondilitis)\n* Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, myeloproliferative disease)\n* Macrocytic anemia (mean corpuscular volume ≥ 100 fL)\n* Current use of immunosuppressive agents including corticosteroids (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, exclusive of inhaled corticosteroids), calcinurin inhibitors (e.g., cyclosporine, tacrolimus), antimetabolites (e.g., azathioprine), or biologics (e.g., OKT3, thymoglobulin)\n* Use of recombinant human erythropoietin formulation within the prev 30 days\n* Pregnancy or lactation\n* Prohibition of RBC transfusion\n* Stay of ≥ 48 hours duration in the ICU of a transferring hospital\n* History of intolerance or hypersensitivity to either enteral or intravenous iron\n* Moribund state in which death is imminent\n* Enrollment in any other clinical trial"}, 'identificationModule': {'nctId': 'NCT01180894', 'acronym': 'IATCI', 'briefTitle': 'IV Iron for the Anemia of Traumatic Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind Comparison of Intravenous Iron Supplementation to Placebo for the Treatment of Anemia of Traumatic Critical Illness', 'orgStudyIdInfo': {'id': '10-0705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Iron sucrose', 'description': '100 mg IV TIW', 'interventionNames': ['Drug: Iron sucrose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pacebo - Normal Saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Iron sucrose', 'type': 'DRUG', 'otherNames': ['Fe sucrose'], 'description': '100 mg IV TIW', 'armGroupLabels': ['Iron sucrose']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['control'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48103', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health Systems', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork Presbyterian Medical Center/Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15201', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98102', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center/University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Fredric M Pieracci, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Health Medical Center, University of Colorado Health Science Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Trauma Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fredric Pieracci', 'investigatorAffiliation': 'Denver Health and Hospital Authority'}}}}