Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT04272606
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2020-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TXA in Spinal Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'catherine-olinger@uiowa.edu', 'phone': '319-384-5892', 'title': 'Catherine Olinger', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 6, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 6, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Vision Change', 'notes': 'Temporary, unexplained vision change. Not attributed to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Dysfunction', 'notes': 'Creatinine increase \\> 20% of baseline on post-operative day 1. All resolved and not attributed to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Complication', 'notes': 'Delayed wound healing. Not attributed to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulmonary Embolism', 'notes': 'Pulmonary embolism 22 days after surgery, after discharge. Determined not to be attributed to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolic stroke', 'notes': 'Embolic stroke 69 days after surgery, following discharge. Determined not to be attributed to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}], 'classes': [{'title': 'Intraoperatively', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Postoperatively (prior to discharge or at day 5, whichever occurred first)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Either Intraoperatively or Postoperatively', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'The number of participants who had red blood cells (RBC) transfused:\n\n1. Intraoperatively\n2. Postoperatively (prior to discharge or at day 5, whichever occurred first)\n3. Either Intraoperatively or Postoperatively', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}], 'classes': [{'title': 'Intraoperatively', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '250'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '176'}]}]}, {'title': 'Postoperatively (prior to discharge or at day 5, whichever occurred first)', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '186'}, {'value': '207', 'groupId': 'OG001', 'lowerLimit': '132', 'upperLimit': '258'}]}]}, {'title': 'Either Intraoperatively or Postoperatively', 'categories': [{'measurements': [{'value': '305', 'groupId': 'OG000', 'lowerLimit': '186', 'upperLimit': '412'}, {'value': '333', 'groupId': 'OG001', 'lowerLimit': '241', 'upperLimit': '428'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'Amount of blood loss:\n\n1. Intraoperatively\n2. Postoperatively (prior to discharge or at day 5, whichever occurred first)\n3. Either Intraoperatively or Postoperatively', 'unitOfMeasure': 'ml per instrumented vertebral level', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Delirium Occurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.', 'unitOfMeasure': 'participants with delirium', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Delirium Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '2.50'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium)', 'unitOfMeasure': '3D-CAM Points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Interleukin-6 Concentration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '35.8'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '68.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperatively and 24 hours postoperatively', 'description': 'Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw.', 'unitOfMeasure': 'pg per ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Postoperative Stay Prior to Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days thru day of discharge', 'description': 'Length of postoperative stay prior to discharge in days', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'FG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '123 subjects were enrolled and consented. Prior to randomization, 37 subjects were excluded and did not get randomized.', 'preAssignmentDetails': '37 subjects were excluded and not randomized due to the following reasons:\n\n* Exclusion criteria was found (14 subjects)\n* Surgery cancelled (8 subjects)\n* Subjects withdrew (5 subjects)\n* Surgery changed to min invasive and so subject did not qualify (3 subjects)\n* Surgeon decision (2 subjects)\n* trial on hold during randomization period (2 subjects)\n* study medication order problems (3 subjects)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam\n\nTranexamic Acid: Antifibrinolytic Agent\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'BG001', 'title': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam\n\nSaline Solution: Placebo\n\nVisual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after\n\n3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '72'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '71'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-21', 'size': 306115, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-14T12:23', 'hasProtocol': True}, {'date': '2023-12-05', 'size': 119341, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-14T12:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2020-02-13', 'resultsFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-17', 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transfusion', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'The number of participants who had red blood cells (RBC) transfused:\n\n1. Intraoperatively\n2. Postoperatively (prior to discharge or at day 5, whichever occurred first)\n3. Either Intraoperatively or Postoperatively'}, {'measure': 'Blood Loss', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'Amount of blood loss:\n\n1. Intraoperatively\n2. Postoperatively (prior to discharge or at day 5, whichever occurred first)\n3. Either Intraoperatively or Postoperatively'}, {'measure': 'Delirium Occurrence', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.'}], 'secondaryOutcomes': [{'measure': 'Delirium Severity', 'timeFrame': 'Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported', 'description': 'Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium)'}, {'measure': 'Change in Interleukin-6 Concentration.', 'timeFrame': 'Preoperatively and 24 hours postoperatively', 'description': 'Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw.'}, {'measure': 'Length of Postoperative Stay Prior to Discharge', 'timeFrame': 'Days thru day of discharge', 'description': 'Length of postoperative stay prior to discharge in days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posterior Lumbar Interbody Fusion', 'Transforaminal Lumbar Interbody Fusion', 'Tranexamic Acid', 'Neurosurgery', 'Delirium'], 'conditions': ['Degenerative Disc Disease']}, 'referencesModule': {'references': [{'pmid': '40276619', 'type': 'DERIVED', 'citation': "Hindman BJ, Olinger CR, Woodroffe RW, Zanaty M, Deifelt Streese C, Zacharias ZR, Houtman JCD, Wendt LH, Ten Eyck PP, O'Connell-Moore DJ, Ray EJ, Lee SJ, Waldschmidt DF, Havertape LG, Nguyen LB, Chen PF, Banks MI, Sanders RD, Howard MA 3rd. Exploratory randomised trial of tranexamic acid to decrease postoperative delirium in adults undergoing lumbar fusion-a trial stopped early. BJA Open. 2025 Apr 14;14:100403. doi: 10.1016/j.bjao.2025.100403. eCollection 2025 Jun."}]}, 'descriptionModule': {'briefSummary': 'Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.', 'detailedDescription': 'This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status.\n\nThe drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-90 years\n2. American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV\n3. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.\n4. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.\n\nExclusion Criteria:\n\n1. ASA class V\n2. Patient unable to consent\n3. Patient with chronic kidney disease stage III or above: baseline plasma creatinine\\>1.5mg/dL\n4. Patient with known liver failure\n5. Patients on anticoagulation or dual antiplatelets (presence of vascular stents).\n6. Patients with artificial valves.\n7. Patients with allergy to TXA\n8. Patients with platelet count \\< 150 000,\n9. Patients with PT\\>15s\n10. Patients with Activated Partial Thromboplastin Time (APPT) \\>38s\n11. History of stroke or (an) unprovoked thromboembolic event(s).\n12. History of intracranial bleeding,\n13. Pregnancy\n14. known defective color vision\n15. history of venous or arterial thromboembolism or active thromboembolic disease\n16. Patients with severe pulmonary or cardiac disease.\n17. Patients who refuse transfusion of blood products\n18. Patients with chronic anemia with Hg\\<8\n19. Patients undergoing lumbar fusion for disease other than DDD (neoplasm)\n20. Patients undergoing lumbar fusion by anterior or lateral approach.\n21. Minimally invasive TLIF are excluded.\n22. Emergent cases.\n23. Women on hormonal contraception\n24. Retinal vein or artery occlusion\n25. Hypercoagulability\n26. Seizure disorder\n27. Current use of tretinoin\n28. Current use of chlorpromazine\n29. Breast feeding'}, 'identificationModule': {'nctId': 'NCT04272606', 'briefTitle': 'TXA in Spinal Fusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation', 'orgStudyIdInfo': {'id': '201912099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': '1:1 randomization, given tranexamic acid during surgery, visual acuity exam', 'interventionNames': ['Drug: Tranexamic Acid', 'Diagnostic Test: Visual Acuity Exam', 'Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1:1 randomization, given standard of care treatment during surgery, visual acuity exam', 'interventionNames': ['Drug: Saline Solution', 'Diagnostic Test: Visual Acuity Exam', 'Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': 'Antifibrinolytic Agent', 'armGroupLabels': ['Treatment']}, {'name': 'Saline Solution', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Visual Acuity Exam', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Eye Exam'], 'description': 'Supplemented into standard of care daily neurological exam on day of surgery and day after', 'armGroupLabels': ['Placebo', 'Treatment']}, {'name': '3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)', 'type': 'DIAGNOSTIC_TEST', 'description': '3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.', 'armGroupLabels': ['Placebo', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Catherine Olinger, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catherine R. Olinger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Catherine R. Olinger', 'investigatorAffiliation': 'University of Iowa'}}}}