Oral Surgery in Patients Taking Direct Oral Anticoagulants (OSDOA)

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Postoperative Hemorrhage; Anticoagulants and Bleeding Disorders; Dentoalveolar Haemorrhage
• Intervention / Treatment: Procedure: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)

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 Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Dental Clinic of Vojvodina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy
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); single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative bleeding event	Bleeding that requires additional surgical procedure	7 days

Collaborators and Investigators

• Sponsor: University of Novi Sad
• Investigators: Principal Investigator: Branislav Bajkin, PhD, University of Novi Sad, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2015
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): August 3, 2020

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: oral anticoagulants; hemorrhage; warfarin; rivaroxaban; oral surgery; dabigatran
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Postoperative Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: 01-11/45-2015 DCV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No