Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-10 @ 2:03 PM
Study NCT ID:
NCT03182751
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2017-06-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Yuan.Brandon@mayo.edu', 'phone': '507-255-6112', 'title': 'Dr. Brandon Yuan', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 7, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 6, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Deep Vein Thrombosis (DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism (PE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Length of hospitalization (approximately 3 to 5 days)', 'description': 'Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Units of Packed Red Blood Cells Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length of hospitalization (approximately 3 to 5 days)', 'description': 'Number of units of packed red blood cells transfused per patient', 'unitOfMeasure': 'units of packed red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Calculated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '1600', 'spread': '1200', 'groupId': 'OG000'}, {'value': '2000', 'spread': '1400', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length of hospitalization (approximately 3 to 5 days)', 'description': 'Total blood loss per patient measured in milliliters (mL)', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects to experience symptomatic Venous Thromboembolism (VTE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Wound Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects diagnosed with a wound complication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '(Myocardial Infarction) MI Diagnosed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects diagnosed with a myocardial infarction', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebrovascular Accident (CVA) Diagnosed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects diagnosed with a cerebrovascular accident', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 months after surgery', 'description': 'Number of subject deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department\n\nTranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department\n\nPlacebo: Looks exactly like the study drug, but it contains no active ingredient'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79.1', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '79.69', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '79.39', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-13', 'size': 220992, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-17T09:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (\\<75 vs. ≥75) and body mass index (\\<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2017-06-07', 'resultsFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-28', 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells', 'timeFrame': 'Length of hospitalization (approximately 3 to 5 days)', 'description': 'Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.'}], 'secondaryOutcomes': [{'measure': 'Number of Units of Packed Red Blood Cells Transfused', 'timeFrame': 'Length of hospitalization (approximately 3 to 5 days)', 'description': 'Number of units of packed red blood cells transfused per patient'}, {'measure': 'Calculated Blood Loss', 'timeFrame': 'Length of hospitalization (approximately 3 to 5 days)', 'description': 'Total blood loss per patient measured in milliliters (mL)'}, {'measure': 'Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects to experience symptomatic Venous Thromboembolism (VTE)'}, {'measure': 'Wound Complications', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects diagnosed with a wound complication'}, {'measure': '(Myocardial Infarction) MI Diagnosed', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects diagnosed with a myocardial infarction'}, {'measure': 'Cerebrovascular Accident (CVA) Diagnosed', 'timeFrame': 'Within 6 months of surgery', 'description': 'Number of subjects diagnosed with a cerebrovascular accident'}, {'measure': 'All-cause Mortality', 'timeFrame': 'At 6 months after surgery', 'description': 'Number of subject deaths'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures', 'Intertrochanteric Fractures']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.', 'detailedDescription': 'The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AO/OTA fracture classification 31A\n* Surgically treated with sliding hip screw or cephalomedullary nail (short or long)\n* Low energy, isolated injury\n\nExclusion Criteria:\n\n* Intracapsular hip fractures: AO/OTA fracture classification 31B-C\n* Polytrauma patients\n* Creatinine clearance less than 30 mL/min\n* History of unprovoked VTE and/or recurrent VTE\n* Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant\n* Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)\n* History of CVA, MI, or VTE within the previous 30 days\n* Coronary stent placement within the previous 6 months\n* Disseminated intravascular coagulation\n* Intracranial hemorrhage'}, 'identificationModule': {'nctId': 'NCT03182751', 'briefTitle': 'Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?', 'orgStudyIdInfo': {'id': '16-004988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic Acid Arm (TXA)', 'description': 'Subjects will be treated with early administration of TXA in the Emergency Department', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'Subjects will be treated with a placebo in the Emergency Department', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': 'Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours', 'armGroupLabels': ['Tranexamic Acid Arm (TXA)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Looks exactly like the study drug, but it contains no active ingredient', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Brandon Yuan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "We do not plan to share IPD with other researchers that are outside of the primary listed researchers within the primary institution where the investigation is being performed. While we intend the share the overall results of the study through peer review, we do not have our institution's IRB approval to share individual participant data outside of the institution."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brandon James Yuan', 'investigatorAffiliation': 'Mayo Clinic'}}}}