Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.

NCT06365242 | Completed

• 1 other identifier: DOACS1_2024
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of DOACs treatment on post-extraction bleeding

Conditions

Post Operative Hemorrhage

Keywords

Direct Oral Anticoagulants; oral Surgical Procedure; Post-operative complications

Outcome Measures

Primary Outcomes (2)

• Peri-operative hemorrhage

  Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe.

  20 minutes to 80 minutes

• Post-operative bleeding

  Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe.

  day 1 to 7 post-operatively

Study Arms (1)

DOACs treated patients

Patients treated with DOACs undergoing oral extractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, 56126, Italy

Location

Related Publications (9)

• 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.

  PMID: 38565933 RESULT

• 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.

  PMID: 37821865 RESULT

• 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: 10.1016/j.ijom.2018.03.009. Epub 2018 Apr 10.

  PMID: 29653869 RESULT

• 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 2018 Sep 26.

  PMID: 30347201 RESULT

• 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: 10.1371/journal.pone.0266011. eCollection 2022.

  PMID: 35390010 RESULT

• 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.

  PMID: 28232717 RESULT

• 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 12.

  PMID: 30611688 RESULT

• 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.

  PMID: 26774397 RESULT

• 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: 10.1016/j.oooo.2016.06.003. Epub 2016 Jun 22.

  PMID: 27554378 RESULT

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Antonio Barone

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Oral Surgery and Implantology, Principal Investigator

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: July 23, 2020
• Primary Completion: July 27, 2021
• Study Completion: December 23, 2022
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)