Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02428868
Status:
UNKNOWN
Last Update Posted:
2015-04-29
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV Iron in Association With Tranexamic Acid for Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D000740', 'term': 'Anemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transfusion', 'timeFrame': '5 days', 'description': 'percentage of patients who receive red-cell transfusion during hospitalization'}], 'secondaryOutcomes': [{'measure': 'Average red-cell packs per patient', 'timeFrame': '5 days'}, {'measure': 'blood loss', 'timeFrame': '5 days', 'description': 'Calculated blood loss per patient from admission to day 5 postoperatively'}, {'measure': 'haemoglobin level', 'timeFrame': 'day 1', 'description': 'haemoglobin level at day 1 postoperatively'}, {'measure': 'haemoglobin level', 'timeFrame': 'day 2'}, {'measure': 'haemoglobin level', 'timeFrame': 'day 5'}, {'measure': 'haemoglobin level', 'timeFrame': 'day 30'}, {'measure': 'haemoglobin level', 'timeFrame': 'day 60'}, {'measure': 'Thromboembolic events', 'timeFrame': 'day 60', 'description': 'stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively.'}, {'measure': 'Post-operative bacterial infection', 'timeFrame': 'day 60', 'description': 'urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection.'}, {'measure': 'number of days in hospital', 'timeFrame': 'day 10', 'description': 'expected period of approximately 5 days'}, {'measure': 'Functional mobility', 'timeFrame': 'day 60', 'description': 'ability to walk more than 10 m or outside home 60 days after hospital discharge.'}, {'measure': 'mortality', 'timeFrame': '5 days', 'description': 'in-hospital mortality'}, {'measure': 'mortality', 'timeFrame': 'day 30'}, {'measure': 'mortality', 'timeFrame': 'day 60'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hip fracture', 'anemia', 'blood transfusion', 'tranexamic acid', 'intravenous iron'], 'conditions': ['Hip Fracture', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '19707842', 'type': 'BACKGROUND', 'citation': 'Hagino T, Ochiai S, Sato E, Maekawa S, Wako M, Haro H. The relationship between anemia at admission and outcome in patients older than 60 years with hip fracture. J Orthop Traumatol. 2009 Sep;10(3):119-22. doi: 10.1007/s10195-009-0060-8. Epub 2009 Aug 26.'}, {'pmid': '22168590', 'type': 'BACKGROUND', 'citation': 'Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.'}, {'pmid': '20613475', 'type': 'RESULT', 'citation': 'Spahn DR. Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology. 2010 Aug;113(2):482-95. doi: 10.1097/ALN.0b013e3181e08e97.'}, {'pmid': '20630042', 'type': 'RESULT', 'citation': 'Serrano-Trenas JA, Ugalde PF, Cabello LM, Chofles LC, Lazaro PS, Benitez PC. Role of perioperative intravenous iron therapy in elderly hip fracture patients: a single-center randomized controlled trial. Transfusion. 2011 Jan;51(1):97-104. doi: 10.1111/j.1537-2995.2010.02769.x.'}, {'pmid': '19926634', 'type': 'RESULT', 'citation': 'Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.'}]}, 'descriptionModule': {'briefSummary': 'It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.', 'detailedDescription': 'Hip fracture is an increasing problem. Anemia is a common finding in these patients with a prevalence ranging from 24% to 44% and is a strong negative prognostic marker. Several studies have explored whether interventions to improve anemia result in better outcomes. Thus, alternatives to allogenic red cell transfusion have been suggested in hip fracture, such as IV iron and tranexamic acid.\n\nThe aim of the study is to test the effect of combination of IV iron with tranexamic acid before and after surgery for hip fracture on incidence of peri-operative red cell transfusion.\n\nIt is a prospective randomized single-blinded monocentric study including 150 patients undergoing hip fracture surgery within 72 h after trauma aged ≥ 60 years divided in 3 groups: Group A (IV fer+Tranexamic acid), Group B (Tranexamic acid), Group C (placebo). The main outcome was percentage of patients who receive red-cell transfusion during hospitalization. Hemoglobin levels up to 60 days post-operatively and incidence of thrombotic events were secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing hip fracture surgery within 72 h after trauma.\n\nExclusion Criteria:\n\n* Vascular events within the last 2 months such as cerebrovascular accident (CVA), Myocardial infarction (MI), Venous Thromboembolism (VTE) and/or recurrent VTE or arterial thrombosis.\n* Patients receiving anticoagulation therapy with warfarin or clopidogrel.\n* History of seizures.\n* Multiple fractures.\n* Transfusion received during admission, prior to surgery (Hb\\< 8g/dl).\n* Creatinine clearance less than 30 mL/min\n* Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant\n* Coronary stent placement within the previous 6 months\n* Disseminated intravascular coagulation\n* Subarachnoid hemorrhage\n* Allergy for tranexamic acid\n* Hypersensitivity to Iron sucrose or any component of the formulation\n* Clinical signs of acute thromboembolic event\n* Malignancy\n* Body weight \\> 100kg\n* Advanced Dementia'}, 'identificationModule': {'nctId': 'NCT02428868', 'briefTitle': 'IV Iron in Association With Tranexamic Acid for Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': "Institut Kassab d'Orthopédie"}, 'officialTitle': 'Use of Combined Tranexamic Acid and Intravenous Iron for Hip Fracture Surgery in Elderly', 'orgStudyIdInfo': {'id': 'P-2015004/AR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic acid - intravenous iron', 'description': 'IV iron (Ferroven®) : 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three.\n\nIV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later.', 'interventionNames': ['Drug: tranexamic acid (Exacyl®)', 'Drug: intravenous iron (Ferroven®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid', 'description': 'IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later.', 'interventionNames': ['Drug: tranexamic acid (Exacyl®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'tranexamic acid (Exacyl®)', 'type': 'DRUG', 'description': '1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later', 'armGroupLabels': ['Tranexamic acid', 'Tranexamic acid - intravenous iron']}, {'name': 'intravenous iron (Ferroven®)', 'type': 'DRUG', 'description': '2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three.', 'armGroupLabels': ['Tranexamic acid - intravenous iron']}, {'name': 'Saline', 'type': 'OTHER', 'description': '20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manouba', 'state': 'La Manouba', 'country': 'Tunisia', 'contacts': [{'name': 'Karim Raies, A. Professor', 'role': 'CONTACT', 'email': 'karim.raies@gmail.com', 'phone': '0021655208602'}], 'facility': "Institut Mohamed Kassab d'Orthopédie", 'geoPoint': {'lat': 36.81006, 'lon': 10.09557}}], 'centralContacts': [{'name': 'Olfa Kaabachi, Professor', 'role': 'CONTACT', 'email': 'olfa.kaabachi@gnet.tn', 'phone': '+21698317381'}], 'overallOfficials': [{'name': 'Olfa Kaabachi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Mohamed Kassab d'Orthopédie"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Kassab d'Orthopédie", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}