Oral Surgery in Patients Taking Direct Oral Anticoagulants

Completed

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

• Registration Number: NCT04505475
• Lead Sponsor: University of Novi Sad

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.

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 Timeline

• Study Start: 2015-05-25
• Status Verified: 2020-08
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Direct oral anticoagulants	Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)	Patients taking dabigatran, ravaroxaban or apixaban
Vitamin K antagonists	Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)	Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5)

Primary Outcome Measures

Name	Time	Method
Postoperative bleeding event	7 days	Bleeding that requires additional surgical procedure

Trial Locations

Locations (1)

Dental Clinic of Vojvodina; 🇷🇸 Novi Sad, Vojvodina, Serbia