Oral Surgery in Patients Taking Direct Oral Anticoagulants and Vitamin K Antagonists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Postoperative bleeding event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postoperative bleeding event
时间窗: 7 days
Bleeding that requires additional surgical procedure
次要结局
未报告次要终点
研究者
Branislav Bajkin
Principal Investigator
University of Novi Sad
