NCT07520890

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Direct Oral Anticoagulants (DOACs)
• Oral Surgical Procedures

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Italy