[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632992":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":37,"collaborators":10,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"University of Pisa","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"DOAC Group",null,"patients receiving uninterrupted DOAC therapy (apixaban, rivaroxaban, edoxaban, or dabigatran)",{"label":13,"type":10,"description":14,"interventionNames":10},"Control Group","patients not receiving any anticoagulant therapy",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Marco Nisi, Prof.","CONTACT","050993193","marco.nisi@unipi.it",[22],{"facility":5,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Pisa","Pi","56126","Italy","IT",{"type":30,"coordinates":31},"Point",[32,33],10.4036,43.70853,{"lat":33,"lon":32},[36],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Rossana Izzetti","Researcher","100632992","oral-biopsy-bleeding-in-patients-on-direct-oral-anticoagulants-doacs-100632992",false,"NCT07520890","Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)","Bleeding Outcomes Following Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants","DOACS_BX","Inclusion Criteria:\n\n* capacity to understand and sign informed consent;\n* documented indication for oral soft tissue biopsy\n\nExclusion Criteria:\n\n* inability to provide consent;\n* congenital or acquired coagulopathy (including haemophilia, von Willebrand disease, thrombocytopenia, or hepatic cirrhosis);\n* active antiplatelet therapy other than low-dose aspirin",true,"ALL","18 Years",{"count":53,"type":54},100,"ESTIMATED","OBSERVATIONAL","Direct oral anticoagulants (DOACs) are increasingly used, but evidence on bleeding risk during oral soft tissue biopsy is limited. This prospective case-control study compared intraoperative, perioperative, and postoperative bleeding in 50 patients on uninterrupted DOAC therapy versus 50 anticoagulant-naive controls undergoing standardized oral soft tissue biopsy with suturing. All bleeding events were managed with local haemostatic measures. The study aims to determine whether DOAC continuation is safe for this procedure.",[58,59],"Direct Oral Anticoagulants (DOACs)","Oral Surgical Procedures",[61,62,63],"direct oral anticoagulants","post-operative bleeding","oral surgery","2026-04-02",{"date":66,"type":67},"2026-04-09","ACTUAL",{"date":69,"type":67},"2026-04-01",{"date":71,"type":54},"2026-12-31",{"name":5,"class":6},1]