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临床试验/NCT04505475
NCT04505475已完成不适用

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

University of Novi Sad1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2015年5月25日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Branislav Bajkin

Principal Investigator

University of Novi Sad

研究点 (1)

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