Anticoagulants and Bleeding Disorders, Dentoalveolar Haemorrhage, Postoperative Hemorrhage, Surgery
Conditions
Keywords
oral anticoagulants, dabigatran, rivaroxaban, warfarin, oral surgery, hemorrhage
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.
Interventions
single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative bleeding event | 7 days | Bleeding that requires additional surgical procedure |
Countries
Serbia