Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT02150720
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2014-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Postoperative Bleeding in Subcapital Femoral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-05-29', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss (ml) after surgery', 'timeFrame': 'The first postoperative 24h', 'description': 'The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Hidden blood loss', 'timeFrame': 'The first postoperative five days', 'description': 'The hidden blood loss is the total blood loss calculated by the formula of Nadler minus the blood loss by drain.'}, {'measure': 'Proportion of patients requiring blood transfusion', 'timeFrame': 'The first postoperative ten days'}, {'measure': 'Units of blood transfused', 'timeFrame': 'The first postoperative ten days'}, {'measure': 'Proportion of patients with wound infection', 'timeFrame': 'The first postoperative month'}, {'measure': 'Proportion of patients with wound dehiscence', 'timeFrame': 'The first postoperative month'}, {'measure': 'Deep venous thrombosis', 'timeFrame': 'The first postoperative ten days'}, {'measure': 'Length of hospital stay', 'timeFrame': 'The first postoperative ten days', 'description': 'Time from hip surgery until hospital discharge'}, {'measure': 'Quality of life measured with the generic EQ-5D -5L', 'timeFrame': 'Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up'}, {'measure': 'Mortality', 'timeFrame': 'During the 12 month of follow-up after surgery'}, {'measure': 'Direct cost', 'timeFrame': 'During the first postoperative month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip fractures', 'Clinical Trial', 'Randomized', 'Fibrin glue', 'Tranexamic acid', 'Blood loss'], 'conditions': ['Hip Fracture', 'Blood Loss']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Martínez-Zapata MJ, Jordán M, Aguilera X, Cánovas E, Urrutia G (en nombre del grupo TRANEXFER). Estudio prospectivo multicéntrico de una cohorte para evaluar la calidad de vida de pacientes intervenidos de fractura subcapital de fémur. Trauma 2014; 25 (4): 188-195.'}, {'pmid': '36045358', 'type': 'DERIVED', 'citation': 'Merchan-Galvis A, Posso M, Canovas E, Jordan M, Aguilera X, Martinez-Zapata MJ. Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery. BMC Musculoskelet Disord. 2022 Aug 31;23(1):827. doi: 10.1186/s12891-022-05775-y.'}], 'seeAlsoLinks': [{'url': 'http://www.mapfre.com/fundacion/html/revistas/trauma/v25n4/docs/v25n4.pdf', 'label': 'Publication of quality of life (subgroup of patients)'}]}, 'descriptionModule': {'briefSummary': 'The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years\n* Patients with unilateral subcapital femoral fracture\n* Patients requiring hip replacement (total or partial)\n* Signed informed consent from the patient or legal representative\n\nExclusion Criteria:\n\n* Known allergy to fibrin glue and tranexamic acid\n* Multiple fractures\n* Pathological fractures\n* Contraceptives or estrogen therapy\n* Use of blood salvage during surgery\n* History compatible with thromboembolic disease:\n\n * Cerebral vascular accident\n * Ischemic heart disease (myocardial infarction, angina )\n * Deep vein thrombosis\n * Pulmonary Embolism\n * Peripheral arterial vasculopathy\n * Patients with thrombogenic arrhythmias\n * Patients with cardiovascular stents\n * Prothrombotic alterations in coagulation'}, 'identificationModule': {'nctId': 'NCT02150720', 'acronym': 'TRANEXFER', 'briefTitle': 'Prevention of Postoperative Bleeding in Subcapital Femoral Fractures', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue', 'orgStudyIdInfo': {'id': 'IIBSP-FAT-2011-103'}, 'secondaryIdInfos': [{'id': 'EC11-341', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health and Social Policy 2011'}, {'id': '2011-006278-15', 'type': 'EUDRACT_NUMBER'}, {'id': 'SA/12/AYU/456', 'type': 'OTHER_GRANT', 'domain': 'Fundación MAPFRE 2012'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic acid', 'description': 'Tranexamic acid, 1g intra-articular before closing the surgery wound', 'interventionNames': ['Drug: Tranexamic Acid', 'Procedure: Electrocauterization']}, {'type': 'EXPERIMENTAL', 'label': 'Fibrin glue', 'description': 'One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,', 'interventionNames': ['Drug: Fibrin glue', 'Procedure: Electrocauterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual hemostasia', 'description': 'Electrocauterization', 'interventionNames': ['Procedure: Electrocauterization']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['Amchafibrin'], 'description': '1g intra-articular before closing the wound surgery', 'armGroupLabels': ['Tranexamic acid']}, {'name': 'Fibrin glue', 'type': 'DRUG', 'otherNames': ['Evicel'], 'description': '5mL intra-articular before closing the wound surgery', 'armGroupLabels': ['Fibrin glue']}, {'name': 'Electrocauterization', 'type': 'PROCEDURE', 'description': 'Coagulation blood from vessels by means of a electrocautery.', 'armGroupLabels': ['Fibrin glue', 'Tranexamic acid', 'Usual hemostasia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol de Badalona', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Mútua Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Terrassa-Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'MJ Martínez-Zapata, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}