Oral Surgery in Patients Taking Direct Oral Anticoagulants

NCT04505475 | Completed

• 1 other identifier: 01-11/45-2015 DCV
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anticoagulants and Bleeding Disorders; Surgery; Postoperative Hemorrhage; Dentoalveolar Haemorrhage

Keywords

oral anticoagulants; dabigatran; rivaroxaban; warfarin; oral surgery; hemorrhage

Outcome Measures

Primary Outcomes (1)

• Postoperative bleeding event

  Bleeding that requires additional surgical procedure

  7 days

Study Arms (2)

Direct oral anticoagulants

Patients taking dabigatran, ravaroxaban or apixaban

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)

Procedure: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)

Interventions

Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing) PROCEDURE

single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy

Direct oral anticoagulants; Vitamin K antagonists

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

Dental Clinic of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 38580558 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Postoperative Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Branislav Bajkin, PhD

  University of Novi Sad, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: May 25, 2015
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)