Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pisa
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
capacity to understand and sign informed consent;
documented indication for oral soft tissue biopsy
Disqualifiers
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
Trial population
Patients eligible for oral biopsy
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: DOAC Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
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)
Time frame
duration of the intervention2
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.
Time frame
80 minutes3
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).
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov