[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632590":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":42,"locations":47,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":26,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Warfarin Dosing with Vitamin K","EXPERIMENTAL","Patients will receive their standard warfarin dosing before, during, and after their procedure. This is in addition to a one time dose of oral vitamin K pre-procedure.",[13,14],"Drug: Vitamin K","Drug: Warfarin (standard without loading)",{"label":16,"type":10,"description":17,"interventionNames":18},"Loading Warfarin Dosing with Vitamin K","Patients will receive their standard warfarin dosing before and during their procedure. On the night following the procedure, they will receive a one time loading dose of warfarin (twice their normal dose). Patients will then resume normal dosing of warfarin. This is in addition to a one time dose of oral vitamin K pre-procedure.",[13,19],"Drug: Warfarin (standard with loading)",[21,27,33],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vitamin K","10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Warfarin (standard without loading)","Patients receive their standard warfarin dosing without interruption.",[9],[32],"Coumadin",{"type":22,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Warfarin (standard with loading)","Patients receive their standard warfarin dosing without interruption; patients also receive a one time loading dose (twice normal dose) of warfarin on the evening following their procedure.",[16],[32],[39],{"name":40,"affiliation":5,"role":41},"Geoffrey Barnes, MD","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":26,"email":46},"CONTACT","734 936-4000","gbarnes@med.umich.edu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Michigan Medicine","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-83.74088,42.27756,{"lat":60,"lon":59},[63],{"name":40,"role":44,"phone":45,"phoneExt":26,"email":46},{"type":41,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Geoffrey Barnes","Associate Professor of Internal Medicine",[68],{"name":69,"class":70},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100632590","phase-4-vitamin-k-for-perioperative-warfarin-management-100632590",false,"NCT07515664","Vitamin K for Perioperative Warfarin Management","Vitamin K Reversal of INR for Perioperative Management of Warfarin: : A Pilot Study to Assess Feasibility","Inclusion Criteria:\n\n* Warfarin therapy for ≥3 months\n* Use of home INR testing equipment\n* Scheduled for a surgical procedure that requires INR ≤ 1.5 (typically achieved with warfarin interruption)\n* INR ≤ 4 on day 7-10 prior to procedure\n\nExclusion Criteria:\n\n* Surgical procedure does not require INR ≤1.5 (typically achieved with warfarin interruption)\n* Surgical procedure with a high risk of bleeding or complications (urologic procedures, bronchoscopy, epidural injections, nerve blocks, spinal surgery)\n* Warfarin therapy for \\\u003C 3 months\n* Lack of English language proficiency\n* Use of a Heartmate II or HVAD left ventricular assist device\n* Recent thrombotic event (within 3 months)\n* CHA2DS2-VASc score \\>6\n* INR \\>4 on day 7-10 prior to procedure\n* Hypersensitivity to any component of Vitamin K or simple syrup (used in the compounding process)","ALL","18 Years",{"count":81,"type":82},20,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.",[88],"Anticoagulant Therapy","2026-04-06",{"date":91,"type":92},"2026-04-13","ACTUAL",{"date":94,"type":92},"2025-07-03",{"date":96,"type":82},"2026-08",{"name":5,"class":6},1]