Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07520890

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Direct Oral Anticoagulants (DOACs) Oral Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa

Pisa, Pi, 56126, Italy

Location status: Recruiting

Location contact

Marco Nisi, Prof.

CONTACT

[email protected]

050993193

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraoperative bleeding

    Time frame: 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)

  2. Perioperative bleeding (immediate postoperative)

    Time frame: 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.

  3. Postoperative bleeding

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Nisi, Prof.

CONTACT

[email protected]

050993193

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: DOACS_BX

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.