Oral Surgery in Patients Taking Direct Oral Anticoagulants

Surgery Clinical Trial

— OSDOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505475
• Other study ID #: 01-11/45-2015 DCV
• Status: Completed
• Start date: May 25, 2015
• Est. completion date: August 3, 2020

Study information

• Verified date: August 2020
• Source: University of Novi Sad
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Dentoalveolar Haemorrhage
• Hemorrhage
• Hemostatic Disorders
• Postoperative Hemorrhage
• Surgery

Intervention

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

Locations

Country	Name	City	State
Serbia	Dental Clinic of Vojvodina	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative bleeding event	Bleeding that requires additional surgical procedure	7 days