Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT06080893
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2023-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-10-08', 'studyFirstSubmitQcDate': '2023-10-08', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6th and 12th months', 'description': '6th and 12th month mortality information'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['administration, intravenous', 'aged', 'anemia / complications', 'anemia / drug therapy', 'ferric compounds', 'hip fractures / mortality', 'hip fractures / surgery'], 'conditions': ['Hip Fractures', 'Anemia', 'Complication,Postoperative']}, 'referencesModule': {'references': [{'pmid': '34079413', 'type': 'RESULT', 'citation': 'Jones JJ, Mundy LM, Blackman N, Shwarz M. Ferric Carboxymaltose for Anemic Perioperative Populations: A Systematic Literature Review of Randomized Controlled Trials. J Blood Med. 2021 May 26;12:337-359. doi: 10.2147/JBM.S295041. eCollection 2021.'}, {'pmid': '34006287', 'type': 'RESULT', 'citation': 'Clemmensen SZ, Kragholm KH, Melgaard D, Hansen LT, Riis J, Cavallius C, Morch MM, Krogager ML. Association between intravenous iron therapy and short-term mortality risk in older patients undergoing hip fracture surgery: an observational study. J Orthop Surg Res. 2021 May 18;16(1):320. doi: 10.1186/s13018-021-02462-x.'}, {'pmid': '20124051', 'type': 'RESULT', 'citation': 'Parker MJ. Iron supplementation for anemia after hip fracture surgery: a randomized trial of 300 patients. J Bone Joint Surg Am. 2010 Feb;92(2):265-9. doi: 10.2106/JBJS.I.00883.'}, {'pmid': '27195774', 'type': 'RESULT', 'citation': 'Bernabeu-Wittel M, Romero M, Ollero-Baturone M, Aparicio R, Murcia-Zaragoza J, Rincon-Gomez M, Monte-Secades R, Melero-Bascones M, Rosso CM, Ruiz-Cantero A; PAHFRAC-01 Investigators. Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial. Transfusion. 2016 Sep;56(9):2199-211. doi: 10.1111/trf.13624. Epub 2016 May 14.'}, {'pmid': '22353604', 'type': 'RESULT', 'citation': 'Bernabeu-Wittel M, Aparicio R, Romero M, Murcia-Zaragoza J, Monte-Secades R, Rosso C, Montero A, Ruiz-Cantero A, Melero-Bascones M; PAHFRAC-01 investigators. Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project. BMC Musculoskelet Disord. 2012 Feb 21;13:27. doi: 10.1186/1471-2474-13-27.'}, {'pmid': '27624208', 'type': 'RESULT', 'citation': 'Munoz M, Gomez-Ramirez S, Auerbach M. Stimulating erythropoiesis before hip fracture repair for reducing blood transfusion: should we change the hemoglobin cutoff level for defining anemia in females? Transfusion. 2016 Sep;56(9):2160-3. doi: 10.1111/trf.13750. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Hip fractures (HF) are the most common and serious pathology affecting the hip and are associated with a high mortality risk in elderly patients. The prevalence of HF is increasing day by day and surgery is often required for its treatment. Perioperative anemia not only hinders the early recovery and rapid rehabilitation of elderly patients, but also adversely increases the need for blood transfusion, prolongs hospital length of stay (HLS) and even increases the risk of death. Although the blood transfusion threshold is restrictive, approximately one or two thirds of elderly patients with hip fracture surgery (HFS) require blood transfusion during hospitalization, and blood transfusion also has potential side effects.The most important factor in the development of anemia in HF is blood loss; however, there are other mechanisms (renal failure, inflammation, iatrogenic hemodilution) that lead to the selection of different therapeutic approaches.Oral or intravenous iron supplementation is a well-accepted alternative to counteract or prevent perioperative anemia, stimulate erythropoiesis and increase Hgb level in elderly patients. However, there are few studies addressing the relationship between iron therapy and clinical outcomes or mortality. Because ferric carboxymaltose (FCM) allows doses of 2 g in a single session (and can be administered by a short IV infusion of 15-20 minutes), and furthermore, FCM is excellently tolerated and safe for patients. This study was planned to investigate the relationship between FCM supplementation and blood transfusion volume, HLS, postoperative infection and mortality.', 'detailedDescription': 'In the prospective randomized controlled study, a 6 - 12 month follow-up of participants undergoing hip fracture surgery with and without preoperative FCM treatment will be performed. Planning is being made with a total of 200 participants from 100 participants each in the experimental and control groups. Participants over the age of 65 who are diagnosed with hip fracture at Istanbul University Istanbul Faculty of Medicine Orthopedics and Traumatology Clinic will be included in the study. Participants who meet the inclusion criteria will be randomized into 2 groups as participants with and without preopaerative FCM (20 min iv infusion) so as to evaluate laboratory values during hospital stay, perop and postop ES transfusion needs, post-discharge 6th week Hgb value and 6th and 12th month mortality information. The parameters to be examined in clinical controls in the study are age, gender, smoking, comorbidities if any, hip fracture type, surgical treatment, ASA score, body mass index, preop/postop/pre-discharge/6th week Hgb value, perop/postop transfusion amount, preop INR value and 6th month/12th month mortality status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>65 years\n\nExclusion Criteria:\n\n* \\< 65 years\n* Tumor-induced pathological fractures\n* Patients undergoing preop ES replacement\n* Ferric Carboxymaltose drug allergy\n* Multiple trauma\n* Receiving iron therapy in any form at the time of application\n* Those who cannot come to postop clinical follow-up (out of town, etc.)'}, 'identificationModule': {'nctId': 'NCT06080893', 'briefTitle': 'The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures', 'orgStudyIdInfo': {'id': 'Istanbul Faculty of Medicine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferric Carboxymaltose - Administrated Group', 'description': 'Patients eligible for inclusion who received preop FCM intravenous therapy\n\nFCM will be administered intravenously at preop 24th hour according to weight and preop hgb level', 'interventionNames': ['Drug: Ferric carboxymaltose']}, {'type': 'NO_INTERVENTION', 'label': 'Ferric Carboxymaltose - Not Administrated Group', 'description': 'Patients eligible for inclusion who are not received preop FCM intravenous therapy'}], 'interventions': [{'name': 'Ferric carboxymaltose', 'type': 'DRUG', 'otherNames': ['Ferinject'], 'description': 'FCM can be administered in a short IV infusion of 15-20 minutes, allowing doses of 2 g in a single session, and furthermore, FCM is excellently tolerated and safe for patients.\n\nFCM will be administered intravenously at preop 24th hour according to weight and preop hgb level', 'armGroupLabels': ['Ferric Carboxymaltose - Administrated Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Çapa / Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mert Ballı', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant İnvestigator', 'investigatorFullName': 'Mustafa Özkaya', 'investigatorAffiliation': 'Istanbul University'}}}}