Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology)
研究概览
简要总结
Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. The hypothesis of this study is that patients who are managed as outpatients will require interventions at a rate not higher than those managed as inpatients and will have lower direct healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Blood Urea Nitrogen < 18.2 mg/dl
- •Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women
- •Systolic blood pressure ≥ 110 mm Hg
- •Heart rate < 100 beats/min
排除标准
- •Inability to obtain informed consent
- •History of liver disease
- •History of heart failure
- •Syncope that is temporally related to ongoing bleeding
- •Contraindication to proton pump inhibitor use
- •Other conditions that necessitate inpatient evaluation.
- •Inpatients with new onset of GI bleeding
研究组 & 干预措施
Outpatient
干预措施: Outpatient Management of Low-risk Patients (Other)
Inpatient
干预措施: Inpatient Management of Low-risk Patients (Other)
结局指标
主要结局
The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology)
时间窗: Within 7 days of the index presentation to the emergency room
次要结局
未报告次要终点
研究者
Loren Laine
Professor of Medicine
Yale University