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

N/ARecruitingNCT07520890

University of Pisa100 enrolled

Overview

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.

This monocentre prospective case-control study will be conducted at the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, Italy. It will enrol * DOAC group (n=50): uninterrupted apixaban, rivaroxaban, edoxaban, or dabigatran. * Control group (n=50): no anticoagulant therapy. Bleeding will be assessed in patients treated for excisional soft tissue biopsy under local anaesthesia (mepivacaine with vasoconstrictor) and closure with 4-0 resorbable sutures. Bleeding will be classified as: * Intraoperative (during procedure) * Perioperative at 20, 40, 60, and 80 minutes post-procedure * Postoperative by patient diary from day 1 to day 7 (T1-T7) Local haemostatic measures (tranexamic acid-soaked gauze, resuturing, diathermocoagulation) will be applied as needed. DOACs will not be interrupted.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Direct Oral Anticoagulants (DOACs)Oral Surgical Procedures

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * capacity to understand and sign informed consent; * documented indication for oral soft tissue biopsy Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Intraoperative bleeding

bleeding during the surgical procedure causing inadequate visualisation of the operative field and requiring active haemostatic intervention (gauze compression, diathermocoagulation, or haemostatic agents)

Time frame: duration of the intervention

Perioperative bleeding (immediate postoperative)

persistent oozing or frank bleeding within 80 minutes of procedure completion that could not be controlled by standard gauze compression alone. Assessed dichotomously (present/absent) at 20, 40, 60, and 80 minutes post-procedure. If bleeding is detected at 20 minutes, tranexamic acid-soaked gauze will be applied; if bleeding persists at 40 minutes, resuturing or diathermocoagulation will be performed.

Time frame: 80 minutes

Postoperative bleeding

any bleeding beyond 8-12 hours from procedure completion, recorded daily by patients in a clinical diary from day 1 (T1) to day 7 (T7) and graded as: absent; mild (manageable with gauze/tranexamic acid at home); moderate (exuberant clot formation or bleeding requiring outpatient review).

Time frame: 7 days