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

Condition(s) studied

Study summary

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

Primary outcome measure(s)

• Intraoperative bleeding — duration of the intervention
  bleeding during the surgical procedure causing inadequate visualisation of the operative field and requiring active haemostatic intervention (gauze compression, diathermocoagulation, or haemostatic agents)
• Perioperative bleeding (immediate postoperative) — 80 minutes
  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.
• Postoperative bleeding — 7 days
  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).

Trial sites (1)

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