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

NCT07520890 — Recruiting, 100 participants, University of Pisa

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

Registry	NCT07520890, acronym DOACS_BX
Status	Recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	University of Pisa (Other)
Conditions	Direct Oral Anticoagulants (DOACs), Oral Surgical Procedures
Dates	start 2026-04-01, primary completion 2026-05-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-04-09, last updated 2026-04-09
Locations	1 site in Italy

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
DOAC Group			patients receiving uninterrupted DOAC therapy (apixaban, rivaroxaban, edoxaban, or dabigatran)
Control Group			patients not receiving any anticoagulant therapy

+Outcome measures

Primary outcomes

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).

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of Pisa	Pisa, Pi	Italy	Recruiting

+Publications

Results publication: Izzetti R, Cinquini C, Barone A, Nisi M. Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants: A Prospective Cohort Study on Bleeding Outcomes. Oral Dis. 2026 Aug 4. doi: 10.1111/odi.70453. Online ahead of print. PMID 42552608