Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT02569658
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2015-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
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'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, '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': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '152.2', 'spread': '57.3', 'groupId': 'OG000'}, {'value': '178.0', 'spread': '65.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average of 3 days post-operatively', 'description': "Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.", 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Units Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Average of 3 days post-operatively', 'description': 'Units of pack red blood cells that the patients recieved', 'unitOfMeasure': 'Units of PRBCs', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Transfused', 'denoms': 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'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-operative', 'description': 'Must be diagnosed via ultrasound duplex', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulmonary Embolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-operative', 'description': 'Must be diagnosed via CT chest or V/Q lung scan', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-operative', 'description': 'Must be diagnosed via CT scan or MRI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.\n\nTranexamic Acid'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', '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': 'weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84.2', 'spread': '19.6', 'groupId': 'BG000'}, {'value': '88.4', 'spread': '19.1', 'groupId': 'BG001'}, {'value': '86.4', 'spread': '19.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'operative time', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101.1', 'spread': '21.4', 'groupId': 'BG000'}, {'value': '102.7', 'spread': '21.6', 'groupId': 'BG001'}, {'value': '101.9', 'spread': '21.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'reverse total shoulder arthroplasty', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-16', 'size': 453132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-04T09:47', 'hasProtocol': True}, {'date': '2015-03-16', 'size': 489913, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-10-04T09:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2015-10-03', 'resultsFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-20', 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Blood Loss', 'timeFrame': 'Average of 3 days post-operatively', 'description': "Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level."}], 'secondaryOutcomes': [{'measure': 'Number of Units Transfused', 'timeFrame': 'Average of 3 days post-operatively', 'description': 'Units of pack red blood cells that the patients recieved'}, {'measure': 'Number of Patients Transfused', 'timeFrame': 'Average of 3 days post-operatively', 'description': 'Patients who received a post-op transfusion of pack red blood cells'}, {'measure': 'Number of Participants With Deep Vein Thrombosis', 'timeFrame': '30 days post-operative', 'description': 'Must be diagnosed via ultrasound duplex'}, {'measure': 'Number of Participants With Pulmonary Embolism', 'timeFrame': '30 days post-operative', 'description': 'Must be diagnosed via CT chest or V/Q lung scan'}, {'measure': 'Number of Participants With Stroke', 'timeFrame': '30 days post-operative', 'description': 'Must be diagnosed via CT scan or MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Loss', 'Anatomic Total Shoulder Arthroplasty', 'Reverse Total Shoulder Arthroplasty', 'Transfusion', 'Tranexamic Acid']}, 'referencesModule': {'references': [{'pmid': '24986694', 'type': 'BACKGROUND', 'citation': 'Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Nov;23(11):1647-54. doi: 10.1016/j.jse.2014.04.015. Epub 2014 Jun 28.'}, {'pmid': '23927910', 'type': 'BACKGROUND', 'citation': 'Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014 Apr;29(4):856-60. doi: 10.1016/j.arth.2013.07.002. Epub 2013 Aug 6.'}, {'pmid': '24090984', 'type': 'BACKGROUND', 'citation': 'Gupta AK, Chalmers PN, Rahman Z, Bruce B, Harris JD, McCormick F, Abrams GD, Nicholson GP. Reverse total shoulder arthroplasty in patients of varying body mass index. J Shoulder Elbow Surg. 2014 Jan;23(1):35-42. doi: 10.1016/j.jse.2013.07.043. Epub 2013 Sep 30.'}, {'pmid': '24751531', 'type': 'BACKGROUND', 'citation': 'Shields E, Iannuzzi JC, Thorsness R, Noyes K, Voloshin I. Perioperative complications after hemiarthroplasty and total shoulder arthroplasty are equivalent. J Shoulder Elbow Surg. 2014 Oct;23(10):1449-53. doi: 10.1016/j.jse.2014.01.052. Epub 2014 Apr 18.'}, {'pmid': '22623147', 'type': 'BACKGROUND', 'citation': 'Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.'}, {'pmid': '23651507', 'type': 'BACKGROUND', 'citation': 'Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184.'}, {'pmid': '24196467', 'type': 'BACKGROUND', 'citation': 'Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.'}, {'pmid': '24196466', 'type': 'BACKGROUND', 'citation': 'Alshryda S, Mason J, Vaghela M, Sarda P, Nargol A, Maheswaran S, Tulloch C, Anand S, Logishetty R, Stothart B, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013 Nov 6;95(21):1961-8. doi: 10.2106/JBJS.L.00907.'}, {'pmid': '23881695', 'type': 'BACKGROUND', 'citation': 'Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.'}]}, 'descriptionModule': {'briefSummary': 'To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.', 'detailedDescription': 'Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty.\n\nDespite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA.\n\nPurpose of the study is to compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries. With the hypothesis that intravenous TXA will reduce blood loss following TSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient scheduled for a primary anatomic or reverse TSA\n\nExclusion Criteria:\n\n* Allergy to TXA\n* Acquired disturbances of color vision\n* Pre-op use of anticoagulant therapy within five days before surgery\n* History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA\n* Pregnancy or breastfeeding\n* Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement\n* Renal impairment\n* Refusal of blood products\n* Any patient undergoing a revision TSA\n* Patients who decline to participate'}, 'identificationModule': {'nctId': 'NCT02569658', 'briefTitle': 'Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'Rush TXA TSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid Group', 'description': 'Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'armGroupLabels': ['Tranexamic Acid Group']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Gregory Cvetanovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}