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

NCT07520890 | Recruiting

• 1 other identifier: DOACS_biopsy
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Direct Oral Anticoagulants (DOACs); Oral Surgical Procedures

Keywords

direct oral anticoagulants; post-operative bleeding; oral surgery

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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).

  7 days

Study Arms (2)

DOAC Group

patients receiving uninterrupted DOAC therapy (apixaban, rivaroxaban, edoxaban, or dabigatran)

Control Group

patients not receiving any anticoagulant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for oral biopsy

You may qualify if:

• capacity to understand and sign informed consent;
• documented indication for oral soft tissue biopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, Pi, 56126, Italy

RECRUITING

Central Study Contacts

Marco Nisi, Prof.

CONTACT

050993193; marco.nisi@unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 1, 2026
• Primary Completion: May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

IT (1)