Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 1:08 PM
Study NCT ID:
NCT01937559
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2013-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kyle.adams@hawkinsfoundation.com', 'phone': '864-454-7458', 'title': 'Kyle Adams, Research Coordinator', 'organization': 'Hawkins Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from date of surgery to 6 month follow-up. All adverse events from the date of surgery to the final 6 month follow-up were assessed and collected for each patient.', 'eventGroups': [{'id': 'EG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Topical Tranexamic acid (TXA)\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 4, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'Intravenous Tranexamic acid (TXA)', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 4, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ischemic stroke', 'notes': 'ischemic stroke reported 8 months after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Tranexamic acid (TXA) administered topically\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline'}, {'id': 'OG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'Tranexamic acid (TXA) administered intravenously'}], 'classes': [{'categories': [{'measurements': [{'value': '1,062.88', 'spread': '338.78', 'groupId': 'OG000'}, {'value': '1,204.60', 'spread': '403.61', 'groupId': 'OG001'}, {'value': '933.92', 'spread': '351.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital stay, up to 4 days', 'description': 'Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Perioperative Blood Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Tranexamic acid (TXA) administered topically\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline'}, {'id': 'OG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'TXA administered intravenously'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, up to 4 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Blood Units Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Topical Tranexamic acid (TXA)\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline'}, {'id': 'OG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'Intravenous Tranexamic acid (TXA)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, up to 4 days', 'unitOfMeasure': 'blood units', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Surgical Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Tranexamic acid (TXA)\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline'}, {'id': 'OG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'Intravenous Tranexamic acid (TXA)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of hospital stay, up to 4 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Topical Tranexamic acid (TXA)\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline'}, {'id': 'OG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'Intravenous Tranexamic acid (TXA)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.52', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital stay', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Topical Tranexamic acid (TXA)\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline'}], 'classes': [{'title': 'EQ-5D', 'categories': [{'measurements': [{'value': '84.87', 'spread': '13.69', 'groupId': 'OG000'}, {'value': '80.15', 'spread': '16.58', 'groupId': 'OG001'}]}]}, {'title': 'GRoC', 'categories': [{'measurements': [{'value': '6.24', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '5.54', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'SANE', 'categories': [{'measurements': [{'value': '89.06', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '81.08', 'spread': '21.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post-surgery', 'description': '* Single Assessment Numeric Evaluation (SANE): A single question that asks "How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)?" 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder.\n* Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating "The best health you can imagine" and 0 indicating "The worst health you can imagine."\n* Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is "a very great deal worse from before surgery" and 7 being the hip is "a very great deal better from before surgery."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient-reported outcomes were only collected for the two randomized patient groups (Topical tranexamic acid and saline). Patient-reported outcomes were not collected on the intravenous tranexamic acid group, as this group was added for retrospective comparison.'}, {'type': 'SECONDARY', 'title': 'Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Topical Tranexamic acid (TXA)\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline\n\nNormal saline'}], 'classes': [{'title': 'Harris Hip Score', 'categories': [{'measurements': [{'value': '85.03', 'spread': '15.90', 'groupId': 'OG000'}, {'value': '79.95', 'spread': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC', 'categories': [{'measurements': [{'value': '14.64', 'spread': '15.42', 'groupId': 'OG000'}, {'value': '13.46', 'spread': '11.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after surgery', 'description': 'Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes.\n\nWestern Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient-reported outcomes were only collected for the two randomized patient groups (Topical tranexamic acid and saline). Patient-reported outcomes were not collected on the intravenous tranexamic acid group, as this group was added for retrospective comparison.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically'}, {'id': 'FG001', 'title': 'Saline (Control)', 'description': 'Normal saline administered topically (control)'}, {'id': 'FG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'Current standard of care is Tranexamic acid (TXA) administered intravenously. This arm was added as a retrospective comparative group, thus these patients were not randomized during the original study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'screen fail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '122 patients were enrolled and randomized into one of two groups: tranexamic acid administered topically and saline administered topically (control). 61 patients were enrolled in each of the two groups. In addition, 66 patients who received tranexamic acid intravenously were retrospectively analyzed as a comparative group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Tranexamic Acid (TXA)', 'description': 'TXA administered topically\n\nTranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically'}, {'id': 'BG001', 'title': 'Saline', 'description': 'Normal saline administered topically'}, {'id': 'BG002', 'title': 'Intravenous Tranexamic Acid (TXA)', 'description': 'Current standard of care is Tranexamic acid (TXA) administered intravenously. This arm was added as a retrospective comparative group, thus these patients were not randomized during the original study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '86'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '87'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '83'}, {'value': '64.2', 'groupId': 'BG003', 'lowerLimit': '35', 'upperLimit': '87'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '22 patients were withdrawn prior to surgery (11 in the Topical tranexamic acid group and 11 in the saline group). These patients were not included in the analysis population due to their pre-operative withdrawal from the study.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-08', 'size': 347690, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-10T14:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-24', 'studyFirstSubmitDate': '2013-08-30', 'resultsFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2013-09-07', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-24', 'studyFirstPostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Blood Loss', 'timeFrame': 'Duration of hospital stay, up to 4 days', 'description': 'Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Perioperative Blood Transfusions', 'timeFrame': 'Duration of hospital stay, up to 4 days'}, {'measure': 'Number of Blood Units Transfused', 'timeFrame': 'Duration of hospital stay, up to 4 days'}, {'measure': 'Rate of Surgical Infections', 'timeFrame': 'Duration of hospital stay, up to 4 days'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Duration of hospital stay'}, {'measure': 'Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).', 'timeFrame': '6 months post-surgery', 'description': '* Single Assessment Numeric Evaluation (SANE): A single question that asks "How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)?" 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder.\n* Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating "The best health you can imagine" and 0 indicating "The worst health you can imagine."\n* Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is "a very great deal worse from before surgery" and 7 being the hip is "a very great deal better from before surgery."'}, {'measure': 'Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': '6 months after surgery', 'description': 'Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes.\n\nWestern Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tranexamic acid (TXA)'], 'conditions': ['Osteoarthritis', 'Hip Arthropathy', 'Shoulder Arthropathy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.\n\nHips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.\n\nExclusion Criteria:\n\n* allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance \\<30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin \\<11g/dl in females and \\< 12g/dl in males).'}, 'identificationModule': {'nctId': 'NCT01937559', 'briefTitle': 'Topical Tranexamic Acid (TXA) in Joint Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The Hawkins Foundation'}, 'officialTitle': 'Topical Application of Tranexamic Acid in Joint Arthroplasty', 'orgStudyIdInfo': {'id': 'Pro00021253'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical Tranexamic acid (TXA)', 'description': 'Tranexamic acid (TXA) applied topically', 'interventionNames': ['Biological: Tranexamic acid (TXA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Normal saline', 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid (TXA)', 'description': 'Tranexamic acid (TXA) administered intravenously', 'interventionNames': ['Biological: Tranexamic acid (TXA)']}], 'interventions': [{'name': 'Tranexamic acid (TXA)', 'type': 'BIOLOGICAL', 'otherNames': ['Cyklokapron'], 'description': '1.5g of TXA in 100ml normal saline solution', 'armGroupLabels': ['Topical Tranexamic acid (TXA)', 'Tranexamic acid (TXA)']}, {'name': 'Normal saline', 'type': 'DRUG', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Steadman Hawkins Clinic of the Carolinas - Greenville Health System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Brian Burnikel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steadman Hawkins Clinic of the Carolinas - Greenville Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hawkins Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}