Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT04541303
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2020-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'briannacastillo.md@gmail.com', 'phone': '813-765-1619', 'title': 'Brianna Castillo MD', 'organization': 'Univ of Mo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 days', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.\n\nTranexamic acid: tranexamic acid diluted to concentration of 25ml/mg', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.\n\nnormal saline: 0.9% sodium chloride', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Postoperative Hemorrhagic Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.\n\nTranexamic acid: tranexamic acid diluted to concentration of 25ml/mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.\n\nnormal saline: 0.9% sodium chloride'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.028', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'None specified', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'three days', 'description': 'Number of patients who call to report postoperative bleeding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Tranexamic Acid', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.\n\nTranexamic acid: tranexamic acid diluted to concentration of 25ml/mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.\n\nnormal saline: 0.9% sodium chloride'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'three days', 'description': 'The number of patients who return to clinic with postoperative bleeding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rate of Treatment Interventions for Postoperative Hemorrhagic Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Tranexamic Acid', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.\n\nTranexamic acid: tranexamic acid diluted to concentration of 25ml/mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.\n\nnormal saline: 0.9% sodium chloride'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'three days', 'description': 'The number of patients who are treated for postoperative bleeding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Types of Postoperative Hemorrhagic Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Tranexamic Acid', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.\n\nTranexamic acid: tranexamic acid diluted to concentration of 25ml/mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.\n\nnormal saline: 0.9% sodium chloride'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'three days', 'description': 'postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention - Tranexamic Acid', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.\n\nTranexamic acid: tranexamic acid diluted to concentration of 25ml/mg'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.\n\nnormal saline: 0.9% sodium chloride'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.\n\nTranexamic acid: tranexamic acid diluted to concentration of 25ml/mg'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.\n\nnormal saline: 0.9% sodium chloride'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], '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': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '90', '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': 'bleeding', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Patient reported bleeding', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-20', 'size': 188388, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-20T17:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Physician/surgeon, nurses, patient, and patient family will be blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2020-08-28', 'resultsFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-09', 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Postoperative Hemorrhagic Complications', 'timeFrame': 'three days', 'description': 'Number of patients who call to report postoperative bleeding'}, {'measure': 'Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications', 'timeFrame': 'three days', 'description': 'The number of patients who return to clinic with postoperative bleeding'}, {'measure': 'Rate of Treatment Interventions for Postoperative Hemorrhagic Complications', 'timeFrame': 'three days', 'description': 'The number of patients who are treated for postoperative bleeding'}], 'secondaryOutcomes': [{'measure': 'Types of Postoperative Hemorrhagic Complications', 'timeFrame': 'three days', 'description': 'postoperative bleeding complications will be defined as arterial bleed, venous oozing, or organized blood clot/hematoma'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tranexamic acid', 'hemostasis', 'hemorrhagic complication', 'bleeding complication', 'Mohs micrographic surgery', 'granulating wound', 'granulating defect'], 'conditions': ['Postoperative Wound Haemorrhage']}, 'referencesModule': {'references': [{'pmid': '28778259', 'type': 'BACKGROUND', 'citation': 'Tolkachjov SN, Brodland DG, Coldiron BM, Fazio MJ, Hruza GJ, Roenigk RK, Rogers HW, Zitelli JA, Winchester DS, Harmon CB. Understanding Mohs Micrographic Surgery: A Review and Practical Guide for the Nondermatologist. Mayo Clin Proc. 2017 Aug;92(8):1261-1271. doi: 10.1016/j.mayocp.2017.04.009.'}, {'pmid': '16198783', 'type': 'BACKGROUND', 'citation': 'Kimyai-Asadi A, Goldberg LH, Peterson SR, Silapint S, Jih MH. The incidence of major complications from Mohs micrographic surgery performed in office-based and hospital-based settings. J Am Acad Dermatol. 2005 Oct;53(4):628-34. doi: 10.1016/j.jaad.2005.03.023.'}, {'pmid': '22515669', 'type': 'BACKGROUND', 'citation': 'Bunick CG, Aasi SZ. Hemorrhagic complications in dermatologic surgery. Dermatol Ther. 2011 Nov-Dec;24(6):537-50. doi: 10.1111/j.1529-8019.2012.01454.x.'}, {'pmid': '10400410', 'type': 'BACKGROUND', 'citation': 'Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.'}, {'pmid': '26942474', 'type': 'BACKGROUND', 'citation': 'Lin ZX, Woolf SK. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery. Orthopedics. 2016 Mar-Apr;39(2):119-30. doi: 10.3928/01477447-20160301-05. Epub 2016 Mar 4.'}, {'pmid': '23477634', 'type': 'BACKGROUND', 'citation': 'Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.'}, {'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': '32207575', 'type': 'BACKGROUND', 'citation': 'Ausen K, Hagen AI, Ostbyhaug HS, Olafsson S, Kvalsund BJ, Spigset O, Pleym H. Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. BJS Open. 2020 Apr;4(2):216-224. doi: 10.1002/bjs5.50248. Epub 2019 Dec 26.'}, {'pmid': '27840121', 'type': 'BACKGROUND', 'citation': 'de Vasconcellos SJ, de Santana Santos T, Reinheimer DM, Faria-E-Silva AL, de Melo MF, Martins-Filho PR. Topical application of tranexamic acid in anticoagulated patients undergoing minor oral surgery: A systematic review and meta-analysis of randomized clinical trials. J Craniomaxillofac Surg. 2017 Jan;45(1):20-26. doi: 10.1016/j.jcms.2016.10.001. Epub 2016 Oct 13.'}, {'pmid': '23911102', 'type': 'BACKGROUND', 'citation': 'Zahed R, Moharamzadeh P, Alizadeharasi S, Ghasemi A, Saeedi M. A new and rapid method for epistaxis treatment using injectable form of tranexamic acid topically: a randomized controlled trial. Am J Emerg Med. 2013 Sep;31(9):1389-92. doi: 10.1016/j.ajem.2013.06.043. Epub 2013 Jul 30.'}, {'pmid': '32282377', 'type': 'BACKGROUND', 'citation': 'Teoh WY, Tan TG, Ng KT, Ong KX, Chan XL, Hung Tsan SE, Wang CY. Prophylactic Topical Tranexamic Acid Versus Placebo in Surgical Patients: A Systematic Review and Meta-analysis *. Ann Surg. 2021 Apr 1;273(4):676-683. doi: 10.1097/SLA.0000000000003896.'}, {'pmid': '31136475', 'type': 'BACKGROUND', 'citation': 'Ausen K, Pleym H, Liu J, Hegstad S, Nordgard HB, Pavlovic I, Spigset O. Serum Concentrations and Pharmacokinetics of Tranexamic Acid after Two Means of Topical Administration in Massive Weight Loss Skin-Reducing Surgery. Plast Reconstr Surg. 2019 Jun;143(6):1169e-1178e. doi: 10.1097/PRS.0000000000005620.'}, {'pmid': '31832591', 'type': 'BACKGROUND', 'citation': 'Eikebrokk TA, Vassmyr BS, Ausen K, Gravastrand C, Spigset O, Pukstad B. Cytotoxicity and effect on wound re-epithelialization after topical administration of tranexamic acid. BJS Open. 2019 Sep 26;3(6):840-851. doi: 10.1002/bjs5.50192. eCollection 2019 Dec.'}], 'seeAlsoLinks': [{'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf', 'label': 'Ferring Pharmaceuticals Incorporated. Lysteda (tranexamic acid) \\[package insert\\]. Revised October 2013. Accessed May 2020.'}]}, 'descriptionModule': {'briefSummary': 'Bleeding after Mohs micrographic surgery for skin cancer is a low risk complication that can occur. This study aims to determine the effect of a drug, often used to reduce bleeding, called tranexamic acid when applied topically to the skin wound after surgery.', 'detailedDescription': 'To perform a prospective randomized controlled trial to determine the hemostatic effect of TXA soaked gauze (intervention) versus normal saline soaked gauze (control) when applied to granulating defects in the setting of Mohs micrographic surgery.\n\nPatients meeting inclusion criteria will be randomized into two arms once enrolled in the study on the day of their Mohs micrographic surgery (MMS).\n\nOne arm will serve as the control group and will receive normal saline soaked telfa pads to the wound bed upon completion of MMS.\n\nA second arm will receive TXA 25mg/ml at a volume of 1ml/cm2 soaked telfa pads to wound bed upon completion of MMS.\n\nIn both arms, the telfa pads will have a standard pressure dressing placed overtop.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult (18 years or older) patients presenting for Mohs micrographic surgery (MMS) for the treatment of melanoma or nonmelanoma skin cancer (NMSC) with a wound that will be healing by granulation\n\nExclusion Criteria:\n\n* Patients must not be pregnant or breastfeeding.\n* Patients must not have a known allergic reaction or sensitivity to TXA\n* Patient must not have an international normalized ratio (INR) out of therapeutic range if on warfarin.'}, 'identificationModule': {'nctId': 'NCT04541303', 'briefTitle': 'Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Randomized Study on the Topical Application of Tranexamic Acid to Wound Bed for Hemostasis in the Setting Granulating Wounds Following Mohs Micrographic Surgery', 'orgStudyIdInfo': {'id': '2025444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['Lysteda', 'Cyclokapron'], 'description': 'tranexamic acid diluted to concentration of 25ml/mg', 'armGroupLabels': ['Intervention']}, {'name': 'normal saline', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride'], 'description': '0.9% sodium chloride', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri-Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Nicholas Golda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicholas J Golda', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}