Direct Oral Anticoagulants (DOACs)DOACS_BXNCT07520890
Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)
An observational study of Direct Oral Anticoagulants (DOACs) and Oral Surgical Procedures, run by University of Pisa at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Direct Oral Anticoagulants (DOACs), Oral Surgical Procedures
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients eligible for oral biopsy
Who may be able to join
- capacity to understand and sign informed consent;
- documented indication for oral soft tissue biopsy
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Pisa
Pisa, Pi, 56126
Marco Nisi, Prof., 050993193, marco.nisi@unipi.it
About this study
Official title: Bleeding Outcomes Following Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants
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.
Read the 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.
- Keywords
- direct oral anticoagulants, post-operative bleeding, oral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DOAC Group | patients receiving uninterrupted DOAC therapy (apixaban, rivaroxaban, edoxaban, or dabigatran) | |
| Control Group | patients not receiving any anticoagulant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: duration of the intervention
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.
Measured: 80 minutes
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).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Apr 2026
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Direct Oral Anticoagulants (DOACs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossana Izzetti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520890
- Sponsor's protocol ID
- DOACS_biopsy
- Acronym
- DOACS_BX
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 42552608
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Outcomes Following Oral Soft Tissue Biopsy in Patients Receiving Direct Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT07520890
- Acronym / sponsor ID
- DOACS_BX / DOACS_biopsy
- Keywords
- direct oral anticoagulants, post-operative bleeding, oral surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOAC Group | – | –patients receiving uninterrupted DOAC therapy (apixaban, rivaroxaban, edoxaban, or dabigatran) |
| Control Group | – | –patients not receiving any anticoagulant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for oral biopsy
Key inclusion criteria (2 listed)
- capacity to understand and sign informed consent;
- documented indication for oral soft tissue biopsy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 42552608Izzetti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Direct Oral Anticoagulants (DOACs) and Oral Surgical Procedures, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Nisi, Prof. (050993193, marco.nisi@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative bleeding (time frame: duration of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07520890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.