Anticoagulants and Bleeding DisordersOSDOANCT04505475
Oral Surgery in Patients Taking Direct Oral Anticoagulants
An observational study of Anticoagulants and Bleeding Disorders and Surgery, run by University of Novi Sad at 1 site in Serbia.
Trial summary
This study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulants and Bleeding Disorders, Surgery, Postoperative Hemorrhage
- What is being tested?
- Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteSerbia
- Study dates
- 25 May 2015to 3 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Study includes patients taking direct oral anticoagulants (DOACs) and patients taking vitamin K antagonists (VKA) who require oral surgical procedure. The groups will be matched with respect to oral surgical procedure i.e. operative trauma.
Who may be able to join
- Male and female patients over 18 years
- Patients taking regularly direct anticoagulant therapy: dabigatran, rivaroxaban or apixaban (DOACs group)
- Patients taking regularly acenocoumarol with INR 2.0-3.5 on the day of the surgery (VKA group)
- Indication for oral surgical procedure
- Signed informed consent
Who cannot join
- Liver or renal disease
- Coagulopathy
- Pregnant or breastfeeding women
- Allergy to lidocaine
- Patients who stopped taking their anticoagulant medication
- Patients taking VKA with INR <2.0 or >3.5 on the day of the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Surgery in Patients Taking Direct Oral Anticoagulants and Vitamin K Antagonists
This study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.
Read the detailed description
Vitamin K antagonists (VKA) are widely used in long term prevention and treatment of thromboembolism. In the last few years direct oral anticoagulants (DOACs) are available for clinical use, mostly in prevention of stroke and systemic embolisms in patients with nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. Numerous studies confirmed that minor oral surgical procedures in patients taking VKA with therapeutic (International Normalized Ratio) INR levels can be safely performed without therapy interruption if proper local haemostatic measures are applied. Similar recommendations were given for the dental treatment of patients taking DOACs, but there is a lack of clinical studies. The aim of this study is to assess the incidence of bleeding complications after oral surgery in patients who continue their DOACs or VKA medications.
- Conditions
- Anticoagulants and Bleeding Disorders, Surgery, Postoperative Hemorrhage, Dentoalveolar Haemorrhage
- Being tested
- Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)
- Keywords
- oral anticoagulants, dabigatran, rivaroxaban, warfarin, oral surgery, hemorrhage
- Medical subject headings
- Hemostatic Disorders, Postoperative Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)Procedure or surgery
single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy
| Study group | Role | What they receive |
|---|---|---|
| Direct oral anticoagulants | Patients taking dabigatran, ravaroxaban or apixaban Receives: Procedure: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing) | |
| Vitamin K antagonists | Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5) Receives: Procedure: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bleeding event
Bleeding that requires additional surgical procedure
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 posted10 Aug 2020
- Study start25 May 2015
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
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 Anticoagulants and Bleeding DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Branislav Bajkin, University of Novi Sad
- Investigators
- Branislav Bajkin, PhD, Principal investigator, University of Novi Sad, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505475
- Sponsor's protocol ID
- 01-11/45-2015 DCV
- Acronym
- OSDOA
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bajkin BV, Tadic AJ, Komsic JJ, Vuckovic BA. Risk of dentoalveolar surgery postoperative bleeding in patients taking direct oral anticoagulants and vitamin K antagonists: A prospective observational study. J Craniomaxillofac Surg. 2024 Jun;52(6):772-777. doi: 10.1016/j.jcms.2024.03.035. Epub 2024 Apr 1.
PubMed 38580558
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Surgery in Patients Taking Direct Oral Anticoagulants and Vitamin K Antagonists
- ClinicalTrials.gov ID
- NCT04505475
- Acronym / sponsor ID
- OSDOA / 01-11/45-2015 DCV
- Conditions
- Anticoagulants and Bleeding Disorders, Surgery, Postoperative Hemorrhage, Dentoalveolar Haemorrhage
- Keywords
- oral anticoagulants, dabigatran, rivaroxaban, warfarin, oral surgery, hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 25 May 2015 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 10 Aug 2020 (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.
This study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.
Detailed description
Vitamin K antagonists (VKA) are widely used in long term prevention and treatment of thromboembolism. In the last few years direct oral anticoagulants (DOACs) are available for clinical use, mostly in prevention of stroke and systemic embolisms in patients with nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. Numerous studies confirmed that minor oral surgical procedures in patients taking VKA with therapeutic (International Normalized Ratio) INR levels can be safely performed without therapy interruption if proper local haemostatic measures are applied. Similar recommendations were given for the dental treatment of patients taking DOACs, but there is a lack of clinical studies. The aim of this study is to assess the incidence of bleeding complications after oral surgery in patients who continue their DOACs or VKA medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct oral anticoagulants | – | Procedure: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)Patients taking dabigatran, ravaroxaban or apixaban |
| Vitamin K antagonists | – | Procedure: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study includes patients taking direct oral anticoagulants (DOACs) and patients taking vitamin K antagonists (VKA) who require oral surgical procedure. The groups will be matched with respect to oral surgical procedure i.e. operative trauma.
Key inclusion criteria (5 listed)
- Male and female patients over 18 years
- Patients taking regularly direct anticoagulant therapy: dabigatran, rivaroxaban or apixaban (DOACs group)
- Patients taking regularly acenocoumarol with INR 2.0-3.5 on the day of the surgery (VKA group)
- Indication for oral surgical procedure
- Signed informed consent
Key exclusion criteria (6 listed)
- Liver or renal disease
- Coagulopathy
- Pregnant or breastfeeding women
- Allergy to lidocaine
- Patients who stopped taking their anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy | Procedure or surgery | Direct oral anticoagulants, Vitamin K antagonists |
Primary outcome
Postoperative bleeding event
Time frame: 7 days
Bleeding that requires additional surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Derived from this study: PubMed 38580558Bajkin BV, Tadic AJ, Komsic JJ, Vuckovic BA. Risk of dentoalveolar surgery postoperative bleeding in patients taking direct oral anticoagulants and vitamin K antagonists: A prospective observational study. J Craniomaxillofac Surg. 2024 Jun;52(6):772-777. doi: 10.1016/j.jcms.2024.03.035. Epub 2024 Apr 1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Branislav Bajkin, PhD principal investigator
University of Novi Sad, Faculty of Medicine
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 Anticoagulants and Bleeding Disorders and Surgery, run by University of Novi Sad at 1 site in Serbia.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 13 Aug 2020. 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 Serbia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative bleeding event (time frame: 7 days). 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 NCT04505475, 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 13 Aug 2020.