Bleeding after oral soft tissue biopsy in people taking DOAC blood thinners

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

This study will test whether continuing DOAC blood thinners is safe for people having an excisional oral soft tissue biopsy by comparing bleeding in 50 patients on uninterrupted DOACs with 50 patients not on anticoagulants.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pisa (Academic / other)
• Locations: 1 site (Pisa, Pi)
• Trial ID: NCT07520890 on ClinicalTrials.gov

What this trial studies

This prospective case-control study at the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, compares bleeding outcomes in 50 patients who continue DOAC therapy and 50 anticoagulant‑naive controls undergoing a standardized excisional oral soft tissue biopsy under local anesthesia with resorbable sutures. Bleeding will be recorded intraoperatively, at set perioperative timepoints up to 80 minutes, and by patient diary from postoperative days 1 through 7. Local haemostatic measures (tranexamic acid‑soaked gauze, resuturing, diathermocoagulation) will be applied as needed and DOACs will not be interrupted. The study aims to clarify whether continuing DOACs is safe for this specific oral surgical procedure.

Who should consider this trial

Good fit: Adults who need an excisional oral soft tissue biopsy, can provide informed consent, and either are taking a DOAC or are not on anticoagulants, without congenital or acquired coagulopathy and not on active antiplatelet therapy other than low‑dose aspirin.

Not a fit: Patients with known bleeding disorders, active non‑aspirin antiplatelet therapy, severe liver disease, or who require different or more extensive oral procedures may not benefit from the study's findings.

Why it matters

Potential benefit: If successful, patients on DOACs may be able to continue their anticoagulant therapy for oral soft tissue biopsies, avoiding interruption and reducing thromboembolic risk while maintaining manageable bleeding control.

How similar studies have performed: Existing evidence on DOAC management for oral soft tissue biopsy is limited and mixed, so this prospective standardized comparison is relatively novel for this procedure.

Eligibility criteria

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

Where this trial is running

Pisa, Pi

• University of Pisa — Pisa, Pi, Italy (Recruiting)

Study contacts

• Study coordinator: Marco Nisi, Prof.

Conditions Direct Oral Anticoagulants; Oral Surgical Procedures; direct oral anticoagulants; post-operative bleeding; oral surgery