Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Peri-operative hemorrhage
研究概览
简要总结
Evaluation of DOACs treatment on post-extraction bleeding
详细描述
Consecutive patients requiring at least one dental extraction were enrolled. DOACs regimen was either maintained or suspended. Patients were classified in subgroups depending on the number of teeth extracted per procedure (≤ 3 or > 3), the need for flap raising and the performance of osteotomy. Bleeding was recorded intraoperatively, perioperatively at 20, 40, 60 and 80 minutes after the procedure, and in the first seven days post-operatively.
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
- •age >18 years
- •patients under pharmacological treatment with DOACs
- •patients requiring at least one dental extraction
- •patients willing to take part in the study and to sign informed consent
排除标准
- •patients below 18 years of age
- •patients treated with antiplatelet therapy or vitamin K antagonists
- •patients presenting with an International Normalized Ratio (INR) >3.0
- •patients suffering from congenital or acquired coagulopathies (e.g. haemophilia, coagulation factors deficiency, von Willebrand disease, thrombocytopenia, cirrhosis)
结局指标
主要结局
Peri-operative hemorrhage
时间窗: 20 minutes to 80 minutes
Evaluation of early post-operative hemorrhage classified as absent, mild, oozing, moderate, and severe.
Post-operative bleeding
时间窗: day 1 to 7 post-operatively
Evaluation of post-operative bleeding classified as absent, mild, oozing, moderate, and severe.
次要结局
未报告次要终点
研究者
Antonio Barone
Full Professor of Oral Surgery and Implantology, Principal Investigator
University of Pisa