RecruitingNCT07520890

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

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


Sponsor

University of Pisa

Enrollment

100 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria3

  • 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

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Locations(1)

University of Pisa

Pisa, Pi, Italy

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NCT07520890


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