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 groups

Locations

1
University of Pisa56126, PisaPi, Italy

Sponsors and collaborators

University of Pisa

Lead sponsor