Bleeding Outcomes Following Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants

What this Trial Is About

Researchers are evaluating the bleeding risk associated with continuing direct oral anticoagulants (DOACs) during oral soft tissue biopsy, a common oral surgical procedure. This prospective case-control study compares bleeding outcomes in patients who remain on DOAC therapy versus those not on any anticoagulant. The goal is to understand if uninterrupted DOAC use is safe during this procedure, which is important because evidence on bleeding risk in this context is limited. The study enrolls two groups: 50 patients on uninterrupted DOACs (apixaban, rivaroxaban, edoxaban, or dabigatran) and 50 patients not using any anticoagulants. All participants undergo a standardized excisional soft tissue biopsy under local anesthesia with mepivacaine and vasoconstrictor, followed by closure with resorbable sutures. Bleeding is monitored during the intervention, at multiple time points up to 80 minutes after, and by patient diaries from day 1 to day 7 post-procedure. Local haemostatic measures are applied as needed. Participants will have their bleeding carefully assessed intraoperatively, perioperatively, and postoperatively. Researchers collect detailed bleeding data during and after the biopsy using timed assessments and patient-reported diaries. All bleeding events are managed with local treatments such as tranexamic acid-soaked gauze or resuturing. The study takes place at a single center and involves adults aged 18 and older who can provide informed consent. The total observation period for bleeding outcomes extends to 7 days post-biopsy.

Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)