Oral Surgery in Patients Taking Direct Oral Anticoagulants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Surgery in Patients Taking Direct Oral Anticoagulants and Vitamin K Antagonists

Conditions
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Dentoalveolar Haemorrhage, Surgery, Anticoagulants and Bleeding Disorders, Postoperative Hemorrhage

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Direct oral anticoagulants<br>Patients taking dabigatran, ravaroxaban or apixaban | Procedure: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)<br>* single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy<br>|
| Vitamin K antagonists<br>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)<br>* single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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warfarin, oral anticoagulants, dabigatran, rivaroxaban, oral surgery, hemorrhage