Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Association between non-variceal UGIB and the use of different drugs
研究概览
简要总结
- To study the association between non-variceal UGIB and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy.
- To compare the severity of bleeding related to specified drugs.
- To determine risk factors associated with non-variceal UGIB.
详细描述
Upper gastrointestinal bleeding (UGIB) carries a high mortality, especially in elderly patients having co-morbidities, and the incidence of non-variceal and variceal bleeding is reported to be 3.5% and 15%, respectively.
Atrial fibrillation, deep vein thrombosis, pulmonary embolism, and other conditions require anticoagulation, non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet therapy putting the patients at high risk of hemorrhage.
The latest American Heart Association (AHA) report on cardiovascular diseases suggests a doubling of the prevalence of atrial fibrillation by 2030 compared to 2010. The need to institute anticoagulation for this condition, both as primary and secondary prevention, will automatically increase the number of UGIB cases. An improvement in this regard has occurred with the advent of direct oral anticoagulants (DOACs) which have been shown to be non-inferior to vitamin K antagonists (VKAs).
In the event of UGIB, the Rockall score is a valid prediction score, repeatedly confirmed to assess the risk of patients with non-variceal bleeding. The management of UGIB is commonly adapted according to this score. Identifying high-risk patients who may benefit from longer hospitalization is crucial.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (aged 18 years and above) presented with signs and symptoms of UGIB (hematemesis and/or melena)
排除标准
- •Variceal bleeding
- •Age below 18 years
- •Pregnant women
- •Consent refusal
结局指标
主要结局
Association between non-variceal UGIB and the use of different drugs
时间窗: through study completion, an average of 1 year
observation the association between the incedience of Non-variceal upper Gastrointestinal Bleeding and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy
次要结局
- The severity of Non-variceal bleeding related to specified drugs.(through study completion, an average of 1 year)
- Risk factors associated with non-variceal upper gastrointestinal bleeding(through study completion, an average of 1 year)
研究者
Nada Abdelfattah Ahmed
Principal investigator
Assiut University