Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-01 @ 3:58 PM
Study NCT ID:
NCT03923959
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2019-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'halle.becker@pennmedicine.upenn.edu', 'phone': '7175441401', 'title': 'Halle Becker', 'organization': 'LancasterGH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution\n\nTranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution', 'otherNumAtRisk': 146, 'deathsNumAtRisk': 146, 'otherNumAffected': 69, 'seriousNumAtRisk': 146, 'deathsNumAffected': 16, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': '100 cc normal saline\n\nPlacebo: 100 cc normal saline', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 57, 'seriousNumAtRisk': 137, 'deathsNumAffected': 12, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hyperglycemia (worsening of condition -> death)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute infarct in R parietal region (pt released on hospice)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-operative respiratory failure with hypercarbia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Pt was demonstrating a general decline. Pt started hospice care and expired due to multiple co-morbidities.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution\n\nTranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc normal saline\n\nPlacebo: 100 cc normal saline\n\nIncludes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.013', 'ciLowerLimit': '0.5597', 'ciUpperLimit': '1.834', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.307', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "A two-sample proportion test was also completed; the test utilized an α \\< 0.049 to account for the O'Brien-Fleming adjustment. The p-value for the two-sample proportion test was 0.966."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 Months', 'description': 'Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who underwent treatment.'}, {'type': 'SECONDARY', 'title': 'Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution\n\nTranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc normal saline\n\nPlacebo: 100 cc normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.183', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance was the standard α = 0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 Months', 'description': 'Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution\n\nTranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc normal saline\n\nPlacebo: 100 cc normal saline\n\nIncludes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.729', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance was the standard α = 0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Determine differences between the groups in 30 day readmission rates.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution\n\nTranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc normal saline\n\nPlacebo: 100 cc normal saline\n\nIncludes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.655', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance was the standard α = 0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days', 'description': 'Death within 90 days post hip surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Includes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7832', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance was the standard α = 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.', 'description': 'Length of stay immediately post study intervention/surgery for hip fracture', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution\n\nTranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution'}, {'id': 'FG001', 'title': 'Placebo', 'description': '100 cc normal saline\n\nPlacebo: 100 cc normal saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant enrolled twice for separate hip fractures - one enrollment removed.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'One participant was enrolled twice for separate hip fractures, so one of the enrollments was removed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution\n\nTranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution'}, {'id': 'BG001', 'title': 'Placebo', 'description': '100 cc normal saline\n\nPlacebo: 100 cc normal saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'spread': '11', 'groupId': 'BG000'}, {'value': '86.0', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '87.2', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participant enrolled twice for separate hip fractures - one enrollment removed.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-17', 'size': 528148, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-30T11:12', 'hasProtocol': True}, {'date': '2024-02-07', 'size': 265439, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-25T16:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All OR pharmacists are un-blinded to subject randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2019-04-18', 'resultsFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2019-04-22', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-08', 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.', 'timeFrame': '3 Months', 'description': 'Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.'}], 'secondaryOutcomes': [{'measure': 'Complication Rate', 'timeFrame': '3 Months', 'description': 'Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.'}, {'measure': 'Hospital Readmission', 'timeFrame': '30 Days', 'description': 'Determine differences between the groups in 30 day readmission rates.'}, {'measure': 'Mortality Rate', 'timeFrame': '90 Days', 'description': 'Death within 90 days post hip surgery'}, {'measure': 'Length of Stay', 'timeFrame': 'From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.', 'description': 'Length of stay immediately post study intervention/surgery for hip fracture'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood', 'Transfusion', 'Hip', 'Fracture', 'Surgery', 'Replacement', 'Trauma'], 'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '27492116', 'type': 'BACKGROUND', 'citation': 'Farrow LS, Smith TO, Ashcroft GP, Myint PK. A systematic review of tranexamic acid in hip fracture surgery. Br J Clin Pharmacol. 2016 Dec;82(6):1458-1470. doi: 10.1111/bcp.13079. Epub 2016 Sep 20.'}, {'pmid': '20190103', 'type': 'BACKGROUND', 'citation': 'Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg. 2010 Mar;18(3):132-8.'}, {'pmid': '25378512', 'type': 'BACKGROUND', 'citation': 'Ponnusamy KE, Kim TJ, Khanuja HS. Perioperative blood transfusions in orthopaedic surgery. J Bone Joint Surg Am. 2014 Nov 5;96(21):1836-44. doi: 10.2106/JBJS.N.00128.'}, {'pmid': '19007970', 'type': 'BACKGROUND', 'citation': 'Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.'}, {'pmid': '8874456', 'type': 'BACKGROUND', 'citation': 'Carson JL, Duff A, Poses RM, Berlin JA, Spence RK, Trout R, Noveck H, Strom BL. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996 Oct 19;348(9034):1055-60. doi: 10.1016/S0140-6736(96)04330-9.'}, {'pmid': '30007789', 'type': 'BACKGROUND', 'citation': 'Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Shores P, Mullen K, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. The Efficacy of Tranexamic Acid in Total Hip Arthroplasty: A Network Meta-analysis. J Arthroplasty. 2018 Oct;33(10):3083-3089.e4. doi: 10.1016/j.arth.2018.06.023. Epub 2018 Jun 27.'}, {'pmid': '29699826', 'type': 'BACKGROUND', 'citation': 'Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Shores P, Mullen K, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. The Safety of Tranexamic Acid in Total Joint Arthroplasty: A Direct Meta-Analysis. J Arthroplasty. 2018 Oct;33(10):3070-3082.e1. doi: 10.1016/j.arth.2018.03.031. Epub 2018 Mar 22.'}, {'pmid': '25889413', 'type': 'BACKGROUND', 'citation': 'Carling MS, Jeppsson A, Eriksson BI, Brisby H. Transfusions and blood loss in total hip and knee arthroplasty: a prospective observational study. J Orthop Surg Res. 2015 Mar 28;10:48. doi: 10.1186/s13018-015-0188-6.'}, {'pmid': '24196467', 'type': 'BACKGROUND', 'citation': 'Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.'}, {'pmid': '24196466', 'type': 'BACKGROUND', 'citation': 'Alshryda S, Mason J, Vaghela M, Sarda P, Nargol A, Maheswaran S, Tulloch C, Anand S, Logishetty R, Stothart B, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013 Nov 6;95(21):1961-8. doi: 10.2106/JBJS.L.00907.'}, {'pmid': '10919295', 'type': 'BACKGROUND', 'citation': 'Benoni G, Lethagen S, Nilsson P, Fredin H. Tranexamic acid, given at the end of the operation, does not reduce postoperative blood loss in hip arthroplasty. Acta Orthop Scand. 2000 Jun;71(3):250-4. doi: 10.1080/000164700317411834.'}, {'pmid': '19483232', 'type': 'BACKGROUND', 'citation': 'Rajesparan K, Biant LC, Ahmad M, Field RE. The effect of an intravenous bolus of tranexamic acid on blood loss in total hip replacement. J Bone Joint Surg Br. 2009 Jun;91(6):776-83. doi: 10.1302/0301-620X.91B6.22393.'}, {'pmid': '26703193', 'type': 'BACKGROUND', 'citation': 'North WT, Mehran N, Davis JJ, Silverton CD, Weir RM, Laker MW. Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2016 May;31(5):1022-6. doi: 10.1016/j.arth.2015.11.003. Epub 2015 Nov 10.'}, {'pmid': '28244907', 'type': 'BACKGROUND', 'citation': 'Kayupov E, Fillingham YA, Okroj K, Plummer DR, Moric M, Gerlinger TL, Della Valle CJ. Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 1;99(5):373-378. doi: 10.2106/JBJS.16.00188.'}, {'pmid': '22704229', 'type': 'BACKGROUND', 'citation': 'Imai N, Dohmae Y, Suda K, Miyasaka D, Ito T, Endo N. Tranexamic acid for reduction of blood loss during total hip arthroplasty. J Arthroplasty. 2012 Dec;27(10):1838-43. doi: 10.1016/j.arth.2012.04.024. Epub 2012 Jun 14.'}, {'pmid': '27113948', 'type': 'BACKGROUND', 'citation': "Fillingham YA, Kayupov E, Plummer DR, Moric M, Gerlinger TL, Della Valle CJ. The James A. Rand Young Investigator's Award: A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Total Knee Arthroplasty: The Same Efficacy at Lower Cost? J Arthroplasty. 2016 Sep;31(9 Suppl):26-30. doi: 10.1016/j.arth.2016.02.081. Epub 2016 Mar 19."}, {'pmid': '25471907', 'type': 'BACKGROUND', 'citation': 'Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. 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Epub 2008 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.', 'detailedDescription': 'A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.\n\nTranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.\n\nThe investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of written informed consent\n2. Age \\> or = to 65 years\n3. Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions\n4. Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation\n\nExclusion Criteria:\n\n1. Indication for closed reduction or percutaneous screw\n2. Allergy to TXA\n3. Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture\n4. Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S \\& C deficiencies, prothrombin gene mutation)'}, 'identificationModule': {'nctId': 'NCT03923959', 'acronym': 'TAHFT', 'briefTitle': 'Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population', 'organization': {'class': 'OTHER', 'fullName': 'Lancaster General Hospital'}, 'officialTitle': 'Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion', 'orgStudyIdInfo': {'id': 'LancasterGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': '100 cc normal saline with 1g of tranexamic acid in solution', 'interventionNames': ['Drug: Tranexamic Acid Injectable Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '100 cc normal saline', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tranexamic Acid Injectable Solution', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': '100 cc normal saline mixed with 1g of tranexamic acid in solution', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '100 cc normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17602', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Heatlh / Penn Medicine', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}], 'overallOfficials': [{'name': 'Gregory Tocks, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn Medicine / Lancaster General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lancaster General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}