Oral Surgery in Patients Taking Direct Oral Anticoagulants

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.

Completed

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Key information

Conditions

Anticoagulants and Bleeding Disorders Cardiovascular Diseases Dentoalveolar Haemorrhage Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Surgery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Clinic of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy

Primary outcomes

Postoperative bleeding event

Time frame: 7 days

Bleeding that requires additional surgical procedure

Sponsors and collaborators

Lead sponsor

University of Novi Sad

Other

Registry information

Official study title

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

Acronym: OSDOA

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Aug 10, 2020
Registry last updated: Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed