Post Operative Hemorrhage Clinical Trial
— DOACS_1Official title:
Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.
NCT number | NCT06365242 |
Other study ID # | DOACS1_2024 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 23, 2020 |
Est. completion date | December 23, 2022 |
Verified date | May 2024 |
Source | University of Pisa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Evaluation of DOACs treatment on post-extraction bleeding
Status | Completed |
Enrollment | 49 |
Est. completion date | December 23, 2022 |
Est. primary completion date | July 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Italy | U.O. Odontostomatologia e Chirurgia del Cavo Orale | Pisa |
Lead Sponsor | Collaborator |
---|---|
University of Pisa |
Italy,
Cabbar 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 — View Citation
Cocero 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 — View Citation
Darwish 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. — View Citation
Hiroshi 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: 10.137 — View Citation
Johnston 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. — View Citation
Lababidi 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: 1 — View Citation
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/s4159 — View Citation
Mauprivez 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 — View Citation
Patel 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peri-operative hemorrhage | Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe. | 20 minutes to 80 minutes | |
Primary | Post-operative bleeding | Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe. | day 1 to 7 post-operatively |
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