Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 12:30 PM
Study NCT ID:
NCT00327106
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2006-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in HIp Fracture Surgery (THIF Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-09', 'studyFirstSubmitDate': '2006-05-17', 'studyFirstSubmitQcDate': '2006-05-17', 'lastUpdatePostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients receiving the transfusion of at least one unit of allogeneic red blood cell', 'timeFrame': 'between the begining of surgery (day 1) and the eighth post-operative day (day 8)'}], 'secondaryOutcomes': [{'measure': 'number of patients receiving the transfusion of at least one unit of allogeneic red blood cell', 'timeFrame': 'between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8)'}, {'measure': 'post-operative major hemorrhage', 'timeFrame': 'day 8'}, {'measure': 'post-operative blood loss', 'timeFrame': 'untill day 8'}, {'measure': 'post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)', 'timeFrame': 'untill six weeks'}, {'measure': 'thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)', 'timeFrame': 'untill six weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hip fracture', 'transfusion', 'tranexamic acid', 'fondaparinux'], 'conditions': ['Hip Fracture']}, 'referencesModule': {'references': [{'pmid': '19926634', 'type': 'DERIVED', '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': 'The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.', 'detailedDescription': 'Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk.\n\nPatients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requiring surgery for an isolated hip fracture of less than 48 hours\n\nExclusion Criteria:\n\n* Contraindication to tranexamic acid\n* Contraindication to fondaparinux\n* Contraindication to general anesthesia associated with a femoral nerve block\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00327106', 'acronym': 'THIF', 'briefTitle': 'Tranexamic Acid in HIp Fracture Surgery (THIF Study)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.', 'orgStudyIdInfo': {'id': '0401129'}, 'secondaryIdInfos': [{'id': 'DGS 2005-01094'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Exacyl', 'interventionNames': ['Drug: Tranexamic acid (Exacyl)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Physiologic serum', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tranexamic acid (Exacyl)', 'type': 'DRUG', 'otherNames': ['Exacyl'], 'description': '15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Étienne-de-Montluc', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 47.27622, 'lon': -1.78013}}], 'overallOfficials': [{'name': 'Paul Zufferey, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Clément CAILLAUX', 'oldOrganization': 'Centre Hospitalier Universitaire de Saint-Etienne'}}}}