Bleeding after oral soft tissue biopsy in people taking DOAC blood thinners

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective case-control study at the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, compares bleeding outcomes in 50 patients who continue DOAC therapy and 50 anticoagulant‑naive controls undergoing a standardized excisional oral soft tissue biopsy under local anesthesia with resorbable sutures. Bleeding will be recorded intraoperatively, at set perioperative timepoints up to 80 minutes, and by patient diary from postoperative days 1 through 7. Local haemostatic measures (tranexamic acid‑soaked gauze, resuturing, diathermocoagulation) will be applied as needed and DOACs will not be interrupted. The study aims to clarify whether continuing DOACs is safe for this specific oral surgical procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pisa
  Pisa, Pi, Italy Recruiting

Study contacts

• Study coordinator: Marco Nisi, Prof.
• Email: marco.nisi@unipi.it
• Phone: 050993193

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.