[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520523":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":61,"collaborators":43,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":43,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":43,"enrollmentInfo":74,"targetDuration":43,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","The control arm will receive the current standard of care. Before incision, local anesthetic (1% lidocaine with 1:100,000 epinephrine) will be injected subcutaneously into the surgical site. The surgical team will inject approximately 0.8mL per square centimeter of the surgical site area (defect area and undermined tissue area).",[13],"Drug: Control (1% lidocaine with 1:100,000 epinephrine)",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental","EXPERIMENTAL","The experimental arm will receive local anesthetic (1% lidocaine with 1:100,000 epinephrine) and TXA (1g\u002F10mL) in a 9:1 volume ratio. This will be injected subcutaneously into the surgical site. The surgical team will inject approximately 0.8mL per square centimeter of the surgical site area (defect area and undermined tissue area).",[19],"Drug: Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)","Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine) and tranexamic acid (1g\u002F10mL), mixed in a 9:1 volume ratio.",[15],[27],"Tranexamic Acid",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Control (1% lidocaine with 1:100,000 epinephrine)","Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine)",[9],[33],"Standard of Care",[35],{"name":36,"affiliation":5,"role":37},"Priyesh Patel, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Connie Ma, MD","CONTACT","2815366877",null,"connie.ma@vumc.org",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.78444,36.16589,{"lat":57,"lon":56},[60],{"name":40,"role":41,"phone":43,"phoneExt":43,"email":43},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Priyesh Patel","Asst. Professor of Otolaryngology","100520523","phase-2-tranexamic-acid-in-nasal-mohs-reconstruction-100520523",false,"NCT06057675","Tranexamic Acid in Nasal Mohs Reconstruction","Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis","Inclusion Criteria:\n\n1. Adults at least 18 years of age undergoing local flap reconstruction (bilobe flap, note flap dorsal nasal flap, advancement flap) of a nasal defect following Mohs micrographic surgery. Reconstructive procedures will be performed by Drs. Yang or Patel in the division of Facial Plastic Surgery in the Department of Otolaryngology, Head and Neck Surgery at Vanderbilt University Medical Center.\n2. No other facial plastic procedure or sinus surgery performed simultaneously.\n3. Lack of all the below exclusion criteria.\n\nExclusion Criteria:\n\n1. Known allergy to TXA\n2. Intracranial bleeding\n3. Known defective color vision\n4. History of venous or arterial thromboembolism\n5. History of coagulation disorder\n6. Active thromboembolic disease\n7. Severe renal impairment (diagnosis of chronic kidney disease)\n8. History of acute myocardial infarction\n9. History of stroke\n10. History of seizure\n11. History of liver failure\n12. Preoperative lab results indicating thrombocytopenia (platelets \\\u003C150,000), increased bleeding risk (PT over 45, INR over 1.2).",true,"ALL","18 Years",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.",[82,83],"Postoperative Bleeding","Skin Cancer Face",[27,85],"Mohs Reconstruction","2025-08-17",{"date":88,"type":89},"2025-08-19","ACTUAL",{"date":91,"type":89},"2024-03-19",{"date":93,"type":76},"2026-06",{"name":5,"class":6},1]