Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Direct Oral Anticoagulants (DOACs), Oral Surgical Procedures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bleeding Outcomes Following Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants
Overview
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.
Primary outcome measures
- Intraoperative bleeding [Time frame: duration of the intervention]
- Perioperative bleeding (immediate postoperative) [Time frame: 80 minutes]
- Postoperative bleeding [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- University of Pisa — Pisa
Publications
- 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
Identifiers
NCT: NCT07520890 · DOACS_biopsy