Post Operative HemorrhageDOACS_1NCT06365242
Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.
An observational study of Post Operative Hemorrhage, run by University of Pisa at 1 site in Italy.
Trial summary
Evaluation of DOACs treatment on post-extraction bleeding Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Hemorrhage
- Type of treatment
- Pill or oral medicine
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jul 2020to 23 Dec 2022
- 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: Consecutive patients referred to the Unit of Dentistry and Oral Surgery for dental extraction between 2021 and 2023 were enrolled in this study. All the study participants signed an informed consent form to be included in the study.
Who may be able to join
- age >18 years
- patients under pharmacological treatment with DOACs
- patients requiring at least one dental extraction
- patients willing to take part in the study and to sign informed consent
Who cannot join
- patients below 18 years of age
- patients treated with antiplatelet therapy or vitamin K antagonists
- patients presenting with an International Normalized Ratio (INR) >3.0
- patients suffering from congenital or acquired coagulopathies (e.g. haemophilia, coagulation factors deficiency, von Willebrand disease, thrombocytopenia, cirrhosis)
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of DOACs treatment on post-extraction bleeding
Read the detailed description
Consecutive patients requiring at least one dental extraction were enrolled. DOACs regimen was either maintained or suspended. Patients were classified in subgroups depending on the number of teeth extracted per procedure (≤ 3 or > 3), the need for flap raising and the performance of osteotomy. Bleeding was recorded intraoperatively, perioperatively at 20, 40, 60 and 80 minutes after the procedure, and in the first seven days post-operatively.
- Conditions
- Post Operative Hemorrhage
- Keywords
- Direct Oral Anticoagulants, oral Surgical Procedure, Post-operative complications
- Medical subject headings
- Postoperative Hemorrhage
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 |
|---|---|---|
| DOACs treated patients | Patients treated with DOACs undergoing oral extractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative hemorrhage
Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe.
Measured: 20 minutes to 80 minutes
Post-operative bleeding
Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe.
Measured: day 1 to 7 post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start23 Jul 2020
- Primary completion27 Jul 2021
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post Operative HemorrhageStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Barone, University of Pisa
- Investigators
- Antonio Barone, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365242
- Sponsor's protocol ID
- DOACS1_2024
- Acronym
- DOACS_1
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available as aggregate and anonymous data for sceintific publication purposes.
Publications
Lee JY, Park SH, Kim DM, Ko KA, Park JY, Lee JS, Jung UW, Cha JK. Risk of post-operative bleeding after dentoalveolar surgery in patients taking anticoagulants: a cohort study using the common data model. Sci Rep. 2024 Apr 2;14(1):7787. doi: 10.1038/s41598-024-57881-7.
PubMed 38565933Darwish G. The Effect of Direct Oral Anticoagulant Therapy (DOACs) on oral surgical procedures: a systematic review. BMC Oral Health. 2023 Oct 11;23(1):743. doi: 10.1186/s12903-023-03427-8.
PubMed 37821865Lababidi E, Breik O, Savage J, Engelbrecht H, Kumar R, Crossley CW. Assessing an oral surgery specific protocol for patients on direct oral anticoagulants: a retrospective controlled cohort study. Int J Oral Maxillofac Surg. 2018 Jul;47(7):940-946. doi: 10.1016/j.ijom.2018.03.009. Epub 2018 Apr 10.
PubMed 29653869Cocero N, Basso M, Grosso S, Carossa S. Direct Oral Anticoagulants and Medical Comorbidities in Patients Needing Dental Extractions: Management of the Risk of Bleeding. J Oral Maxillofac Surg. 2019 Mar;77(3):463-470. doi: 10.1016/j.joms.2018.09.024. Epub 2018 Sep 26.
PubMed 30347201Hiroshi I, Natsuko SY, Yutaka I, Masayori S, Hiroyuki N, Hirohisa I. Frequency of hemorrhage after tooth extraction in patients treated with a direct oral anticoagulant: A multicenter cross-sectional study. PLoS One. 2022 Apr 7;17(4):e0266011. doi: 10.1371/journal.pone.0266011. eCollection 2022.
PubMed 35390010Patel JP, Woolcombe SA, Patel RK, Obisesan O, Roberts LN, Bryant C, Arya R. Managing direct oral anticoagulants in patients undergoing dentoalveolar surgery. Br Dent J. 2017 Feb 24;222(4):245-249. doi: 10.1038/sj.bdj.2017.165.
PubMed 28232717Cabbar F, Cabbar AT, Cosansu K, Cekirdekci EI. Effects of Direct Oral Anticoagulants on Quality of Life During Periprocedural Management for Dental Extractions. J Oral Maxillofac Surg. 2019 May;77(5):904-911. doi: 10.1016/j.joms.2018.11.032. Epub 2018 Dec 12.
PubMed 30611688Johnston S. An evidence summary of the management of patients taking direct oral anticoagulants (DOACs) undergoing dental surgery. Int J Oral Maxillofac Surg. 2016 May;45(5):618-30. doi: 10.1016/j.ijom.2015.12.010. Epub 2016 Jan 7.
PubMed 26774397Mauprivez C, Khonsari RH, Razouk O, Goudot P, Lesclous P, Descroix V. Management of dental extraction in patients undergoing anticoagulant oral direct treatment: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Nov;122(5):e146-e155. doi: 10.1016/j.oooo.2016.06.003. Epub 2016 Jun 22.
PubMed 27554378
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06365242
- Acronym / sponsor ID
- DOACS_1 / DOACS1_2024
- Conditions
- Post Operative Hemorrhage
- Keywords
- Direct Oral Anticoagulants, oral Surgical Procedure, Post-operative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 15 Apr 2024 (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.
Evaluation of DOACs treatment on post-extraction bleeding
Detailed description
Consecutive patients requiring at least one dental extraction were enrolled. DOACs regimen was either maintained or suspended. Patients were classified in subgroups depending on the number of teeth extracted per procedure (≤ 3 or > 3), the need for flap raising and the performance of osteotomy. Bleeding was recorded intraoperatively, perioperatively at 20, 40, 60 and 80 minutes after the procedure, and in the first seven days post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOACs treated patients | – | –Patients treated with DOACs undergoing oral extractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred to the Unit of Dentistry and Oral Surgery for dental extraction between 2021 and 2023 were enrolled in this study. All the study participants signed an informed consent form to be included in the study.
Key inclusion criteria (4 listed)
- age >18 years
- patients under pharmacological treatment with DOACs
- patients requiring at least one dental extraction
- patients willing to take part in the study and to sign informed consent
Key exclusion criteria (4 listed)
- patients below 18 years of age
- patients treated with antiplatelet therapy or vitamin K antagonists
- patients presenting with an International Normalized Ratio (INR) >3.0
- patients suffering from congenital or acquired coagulopathies (e.g. haemophilia, coagulation factors deficiency, von Willebrand disease, thrombocytopenia, cirrhosis)
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
Peri-operative hemorrhage
Time frame: 20 minutes to 80 minutes
Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe.
Post-operative bleeding
Time frame: day 1 to 7 post-operatively
Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe.
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 10 May 2024.
- Results publication: PubMed 38565933Lee JY, Park SH, Kim DM, Ko KA, Park JY, Lee JS, Jung UW, Cha JK. Risk of post-operative bleeding after dentoalveolar surgery in patients taking anticoagulants: a cohort study using the common data model. Sci Rep. 2024 Apr 2;14(1):7787. doi: 10.1038/s41598-024-57881-7.
- Results publication: PubMed 37821865Darwish G. The Effect of Direct Oral Anticoagulant Therapy (DOACs) on oral surgical procedures: a systematic review. BMC Oral Health. 2023 Oct 11;23(1):743. doi: 10.1186/s12903-023-03427-8.
- Results publication: PubMed 29653869Lababidi E, Breik O, Savage J, Engelbrecht H, Kumar R, Crossley CW. Assessing an oral surgery specific protocol for patients on direct oral anticoagulants: a retrospective controlled cohort study. Int J Oral Maxillofac Surg. 2018 Jul;47(7):940-946. doi: 10.1016/j.ijom.2018.03.009. Epub 2018 Apr 10.
- Results publication: PubMed 30347201Cocero N, Basso M, Grosso S, Carossa S. Direct Oral Anticoagulants and Medical Comorbidities in Patients Needing Dental Extractions: Management of the Risk of Bleeding. J Oral Maxillofac Surg. 2019 Mar;77(3):463-470. doi: 10.1016/j.joms.2018.09.024. Epub 2018 Sep 26.
- Results publication: PubMed 35390010Hiroshi I, Natsuko SY, Yutaka I, Masayori S, Hiroyuki N, Hirohisa I. Frequency of hemorrhage after tooth extraction in patients treated with a direct oral anticoagulant: A multicenter cross-sectional study. PLoS One. 2022 Apr 7;17(4):e0266011. doi: 10.1371/journal.pone.0266011. eCollection 2022.
- Results publication: PubMed 28232717Patel JP, Woolcombe SA, Patel RK, Obisesan O, Roberts LN, Bryant C, Arya R. Managing direct oral anticoagulants in patients undergoing dentoalveolar surgery. Br Dent J. 2017 Feb 24;222(4):245-249. doi: 10.1038/sj.bdj.2017.165.
- Results publication: PubMed 30611688Cabbar F, Cabbar AT, Cosansu K, Cekirdekci EI. Effects of Direct Oral Anticoagulants on Quality of Life During Periprocedural Management for Dental Extractions. J Oral Maxillofac Surg. 2019 May;77(5):904-911. doi: 10.1016/j.joms.2018.11.032. Epub 2018 Dec 12.
- Results publication: PubMed 26774397Johnston S. An evidence summary of the management of patients taking direct oral anticoagulants (DOACs) undergoing dental surgery. Int J Oral Maxillofac Surg. 2016 May;45(5):618-30. doi: 10.1016/j.ijom.2015.12.010. Epub 2016 Jan 7.
- Results publication: PubMed 27554378Mauprivez C, Khonsari RH, Razouk O, Goudot P, Lesclous P, Descroix V. Management of dental extraction in patients undergoing anticoagulant oral direct treatment: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Nov;122(5):e146-e155. doi: 10.1016/j.oooo.2016.06.003. Epub 2016 Jun 22.
- Individual participant dataSharing planned: No. Data will be available as aggregate and anonymous data for sceintific publication purposes.
Related trials for Post Operative Hemorrhage
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
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.
Antonio Barone principal investigator
University of Pisa
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 Post Operative Hemorrhage, 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 4 inclusion and 4 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 10 May 2024. 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?
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?
Peri-operative hemorrhage (time frame: 20 minutes to 80 minutes). The study lists 2 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 NCT06365242, which also lists 9 linked publications.
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 10 May 2024.