Oral Surgery in Patients Taking Direct Oral Anticoagulants (OSDOA)

University of Novi Sad

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT04505475

01-11/45-2015 DCV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

82 participants in 2 patient groups

Direct oral anticoagulants

Description:

Patients taking dabigatran, ravaroxaban or apixaban

Treatment:

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

Vitamin K antagonists

Description:

Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5)

Treatment:

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