Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-02 @ 8:13 PM
Study NCT ID:
NCT07116395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-23
First Post:
2025-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated blood loss (EBL) comparison between those who received TXA vs no TXA', 'timeFrame': 'EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure', 'description': 'Less estimated blood loss after surgery for patients who were administered TXA'}], 'secondaryOutcomes': [{'measure': 'Hospital Length of Stay for Patients who received TXA vs no TXA', 'timeFrame': 'EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure', 'description': 'Patient medical records will be reviewed post-operatively and data will be collected in our study specific data sheet.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TXA', 'Anticoagulant', 'Orthopaedic Trauma'], 'conditions': ['Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System']}, 'referencesModule': {'references': [{'pmid': '30674301', 'type': 'BACKGROUND', 'citation': 'Lin YK, Liu KT, Chen CW, Lee WC, Lin CJ, Shi L, Tien YC. How to effectively obtain informed consent in trauma patients: a systematic review. BMC Med Ethics. 2019 Jan 23;20(1):8. doi: 10.1186/s12910-019-0347-0.'}, {'pmid': '34380507', 'type': 'BACKGROUND', 'citation': 'Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, Politis C, Jacobs R, Verhamme P. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021 Aug 11;19(1):54. doi: 10.1186/s12959-021-00303-9.'}, {'pmid': '28222709', 'type': 'BACKGROUND', 'citation': 'Zhang P, Liang Y, Chen P, Fang Y, He J, Wang J. Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2017 Feb 21;18(1):90. doi: 10.1186/s12891-017-1429-0.'}, {'pmid': '29929380', 'type': 'BACKGROUND', 'citation': 'Zhu Q, Yu C, Chen X, Xu X, Chen Y, Liu C, Lin P. Efficacy and Safety of Tranexamic Acid for Blood Salvage in Intertrochanteric Fracture Surgery: A Meta-Analysis. Clin Appl Thromb Hemost. 2018 Nov;24(8):1189-1198. doi: 10.1177/1076029618783258. Epub 2018 Jun 21.'}, {'pmid': '32899057', 'type': 'BACKGROUND', 'citation': 'Deng ZF, Zhang ZJ, Sheng PY, Fu M, Xu DL, He AS, Liao WM, Kang Y. Effect of 3 different anticoagulants on hidden blood loss during total hip arthroplasty after tranexamic acid. Medicine (Baltimore). 2020 Sep 4;99(36):e22028. doi: 10.1097/MD.0000000000022028.'}, {'pmid': '27723454', 'type': 'BACKGROUND', 'citation': 'Hourlier H, Fennema P. Tranexamic acid use and risk of thrombosis in regular users ofantithrombotics undergoing primary total knee arthroplasty: a prospectivecohort study. Blood Transfus. 2018 Jan;16(1):44-52. doi: 10.2450/2016.0160-16. Epub 2016 Oct 4.'}, {'pmid': '25440395', 'type': 'BACKGROUND', 'citation': 'Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.'}]}, 'descriptionModule': {'briefSummary': 'Tranexamic acid, an anti-fibrinolytic agent, is commonly given after induction of general anesthesia in patients undergoing hip and knee arthroplasty. This medication has been associated with decreased blood loss during these procedures, decreased rate of blood transfusion, decreased hospital costs, and no increased risk of thrombotic complication. Given the safety and efficacy of this medication in one subspeciality of orthopedics, it is warranted to investigate the use of it in another subspeciality where blood loss is also of concern. It is also of the utmost importance to identify medications that can safely be given to our population to not only improve patient outcomes but also decrease patient costs in the setting of significant disparities. The application of these findings to orthopedic trauma is not something that has been largely studied or appears in the literature. We hope to fill this gap of knowledge to allow for the application of a safe and beneficial medication to a much larger subset of patients than that that is already receiving the medication routinely. The use of TXA in orthopedic patients who are on anticoagulation versus those who are not is also not something that has been previously studied and another knowledge gap that we hope to fill.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing operative fixation of long bone fractures; Included conditions include femoral neck fractures, intertrochanteric femur fractures, femoral shaft fractures, distal femur fractures, and tibial shaft fractures that undergo surgical management\n\nExclusion Criteria:\n\n* Exclusion criteria for this study will be patients under 18 and prisoners'}, 'identificationModule': {'nctId': 'NCT07116395', 'acronym': 'TXA', 'briefTitle': 'Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Outcomes of Tranexamic Acid With Anticoagulants in Orthopaedic Trauma Procedures: A Prospective Study', 'orgStudyIdInfo': {'id': 'Nazarian_TXA_Prospective2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yes TXA Administered', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}, {'type': 'NO_INTERVENTION', 'label': 'No TXA Administered'}], 'interventions': [{'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'description': 'orthopedic trauma patients who are on anticoagulation', 'armGroupLabels': ['Yes TXA Administered']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Yeng Vue, MA', 'role': 'CONTACT', 'email': 'Yeng.Vue@ucsf.edu', 'phone': '559-761-5636'}, {'name': 'Arbi Nazarian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Molly Mounsey, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Community Regional Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}], 'centralContacts': [{'name': 'Yeng Vue, MA', 'role': 'CONTACT', 'email': 'Yeng.Vue@ucsf.edu', 'phone': '559-761-5636'}, {'name': 'Molly Mounsey, MD', 'role': 'CONTACT', 'email': 'Molly.Mounsey@ucsf.edu', 'phone': '206-499-7945'}], 'overallOfficials': [{'name': 'Arbi Nazarian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently, there is no plan to share IPD with other researchers as the study team does not have full approval to share data from our local collaborative hospital site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbi Nazarian, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Inspire Health Medical Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Arbi Nazarian, MD', 'investigatorAffiliation': 'University of California, San Francisco'}}}}