Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pisa
About this trial
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.
Eligibility criteria
Qualifiers
capacity to understand and sign informed consent;
documented indication for oral soft tissue biopsy
Disqualifiers
inability to provide consent;
congenital or acquired coagulopathy (including haemophilia, von Willebrand disease, thrombocytopenia, or hepatic cirrhosis);
active antiplatelet therapy other than low-dose aspirin
Trial design
Treatments tested in this trial
- Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov