Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-04 @ 8:09 PM
Study NCT ID:
NCT03458468
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2018-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid for the Latarjet Procedure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006406', 'term': 'Hematoma'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded randomized'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematoma Formation', 'timeFrame': 'Postoperative day-1', 'description': 'Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'Postoperative day-1'}, {'measure': 'Total Drain output', 'timeFrame': 'Postoperative day-1', 'description': 'The total drain output of blood post-operatively'}, {'measure': 'Opioid consumption', 'timeFrame': 'Postoperative day-1'}], 'secondaryOutcomes': [{'measure': 'Wound complications', 'timeFrame': 'Postoperative week-2'}, {'measure': 'Total complications', 'timeFrame': 'Postoperative month-4'}, {'measure': 'Haematoma Formation', 'timeFrame': 'Postoperative week-2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tranexamic acid', 'anterior shoulder instability', 'latarjet', 'hematoma'], 'conditions': ['Anterior Shoulder Instability']}, 'referencesModule': {'references': [{'pmid': '26480877', 'type': 'BACKGROUND', 'citation': 'Gillespie R, Shishani Y, Joseph S, Streit JJ, Gobezie R. Neer Award 2015: A randomized, prospective evaluation on the effectiveness of tranexamic acid in reducing blood loss after total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Nov;24(11):1679-84. doi: 10.1016/j.jse.2015.07.029.'}, {'pmid': '28768785', 'type': 'BACKGROUND', 'citation': 'Pauzenberger L, Domej MA, Heuberer PR, Hexel M, Grieb A, Laky B, Blasl J, Anderl W. The effect of intravenous tranexamic acid on blood loss and early post-operative pain in total shoulder arthroplasty. Bone Joint J. 2017 Aug;99-B(8):1073-1079. doi: 10.1302/0301-620X.99B8.BJJ-2016-1205.R1.'}, {'pmid': '28162887', 'type': 'BACKGROUND', 'citation': 'Vara AD, Koueiter DM, Pinkas DE, Gowda A, Wiater BP, Wiater JM. Intravenous tranexamic acid reduces total blood loss in reverse total shoulder arthroplasty: a prospective, double-blinded, randomized, controlled trial. J Shoulder Elbow Surg. 2017 Aug;26(8):1383-1389. doi: 10.1016/j.jse.2017.01.005. Epub 2017 Feb 3.'}, {'pmid': '28902659', 'type': 'BACKGROUND', 'citation': 'Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a double-blinded randomized study evaluating the effectiveness of tranexamic acid in reducing postoperative swelling and haematoma formation after the Latarjet procedure.\n\nThe purpose of this study is to assess the efficacy of tranexamic acid (TXA), given via intra-articular injection at the time of surgery in patients undergoing the Latarjet procedure for shoulder instability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Anterior shoulder instability, warranting the Latarjet procedure\n\nExclusion Criteria:\n\n* Patients with known risk factors for hyper-coagulable state\n* Patients under 16\n* Patients unable to give consent to partake in the trial'}, 'identificationModule': {'nctId': 'NCT03458468', 'briefTitle': 'Tranexamic Acid for the Latarjet Procedure.', 'organization': {'class': 'OTHER', 'fullName': 'Sports Surgery Clinic, Santry, Dublin'}, 'officialTitle': 'A Randomised, Prospective Evaluation on the Effectiveness of Tranexamic Acid in Reducing Postoperative Swelling and Haematoma Formation After the Latarjet Procedure.', 'orgStudyIdInfo': {'id': 'SSC-Latarjet-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Tranexamic Acid 1g IV', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Saline injection', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': '1g Tranexamic acid prior to skin incision', 'armGroupLabels': ['Group A']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Equivalent volume of saline prior to skin incision', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9', 'city': 'Santry', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Sports Surgery Clinic', 'geoPoint': {'lat': 53.39812, 'lon': -6.25268}}], 'overallOfficials': [{'name': 'Hannan Mullett, FRCSI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sports Surgery Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sports Surgery Clinic, Santry, Dublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}