"ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES
研究概览
简要总结
Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension.
Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12 million people worldwide will suffer this condition in the US by 2050 and 17.9 million people in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality .
(AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF increases the risk of stroke five-folds. Stroke prevention is central to the management of patients with atrial fibrillation (AF), and effective stroke prevention requires oral anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral anticoagulant (NOAC) .
It's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All patients with atrial fibrillation :
- •Aged 18 years old or older .
- •Underwent cardiac valve replacement
- •Who have valvular heart disease receiving anticoagulants .
- •Who have non valvular AF in whom CHA2DS 2VASc score 2 or more.
- •Receiving either vitamin K antagonist e.g warfarin or NOAC .
排除标准
- •Patients age less than 18 years old
- •Patients receiving anticoagulants without atrial fibrillations
- •Pregnant patients with AF
- •Patients with AF on Non oral anticoagulants
结局指标
主要结局
incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES
时间窗: 6 months
Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) \& (ORBIT) SCORES will be calculated and compared for all cases .
次要结局
未报告次要终点
研究者
Yasmin Mohamed Mohamed
resident of internal medicine department, Sohag university hospital
Sohag University