Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT03063892
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion
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'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients requiring packed Red Blood Cell transfusion', 'timeFrame': '72 hours', 'description': 'units, perioperative'}], 'secondaryOutcomes': [{'measure': 'intraoperative blood loss', 'timeFrame': '24 hours', 'description': 'mL'}, {'measure': 'postoperative anemia', 'timeFrame': '72 hours', 'description': 'Hgb \\<7g/dL'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over the age of 60 years\n* Hip fracture requiring surgical intervention\n* Signs consent and agrees to participate\n\nExclusion Criteria:\n\n* Under the age of 60\n* Does not sign consent or refuses participation\n* Known hypersensitivity to tranexamic acid\n* Multiple acute fractures\n* Creatinine clearance \\<30\n* History of seizures\n* Active hormone therapy\n* History of coagulation abnormality\n* History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE\n* Myocardial infarction (MI) and/or stents within the past year\n* History of intracranial hemorrhage\n* Acquired defective color vision\n* Patients admitted directly to nursing units or surgery without stay in the Emergency Center\n* Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital'}, 'identificationModule': {'nctId': 'NCT03063892', 'briefTitle': 'Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion', 'organization': {'class': 'OTHER', 'fullName': 'ProMedica Health System'}, 'officialTitle': 'Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients', 'orgStudyIdInfo': {'id': 'GG082015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later.', 'interventionNames': ['Drug: Saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later.', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}], 'interventions': [{'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': 'Tranexamic acid is an antifibrinolytic used to control bleeding', 'armGroupLabels': ['Experimental Arm']}, {'name': 'Saline solution', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'Saline solution is used as the placebo comparator', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gregory Georgiadis, MD', 'role': 'CONTACT', 'email': 'gregory.georgiadisMD@promedica.org', 'phone': '419-291-3858'}], 'facility': 'ProMedica Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'centralContacts': [{'name': 'Kristin Gardner, MSN, RN', 'role': 'CONTACT', 'email': 'kristin.gardner@promedica.org', 'phone': '419-291-5927'}, {'name': 'Michelle Barhite, RPh', 'role': 'CONTACT', 'email': 'michelle.barhite@promedica.org', 'phone': '419-291-7709'}], 'overallOfficials': [{'name': 'Gregory M Georgiadis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ProMedica Toledo Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gregory M Georgiadis MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon', 'investigatorFullName': 'Gregory M Georgiadis MD', 'investigatorAffiliation': 'ProMedica Health System'}}}}