Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Hemospray® intraprocedural bleeding control
研究概览
简要总结
This is an observational, retrospective, analytical, and multicenter study conducted at 17 hospitals. Our research aims to assess the effectiveness of Hemospray® in patients with gastrointestinal bleeding in clinical practice. Besides, we aim to detect predictors of treatment failure defined as unsuccessful immediate hemostasis or rebleeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastrointestinal bleeding treated with Hemospray®.
排除标准
- 未提供
结局指标
主要结局
Hemospray® intraprocedural bleeding control
时间窗: From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.
It refers to the proportion (%) of patients who achieves intraprocedural hemostasis with Hemospray®. Intraprocedural bleeding control is defined as endoscopic observation of bleeding cessation after Hemospray® use.
Rebleeding rate
时间窗: Date of Hemospray® application until rebleeding, assessed up to 48 months
To describe the rebleeding rate (%) after Hemospray®. Rebleeding is defined as a new episode of hematemesis, rectorrhagia or melena; hemoglobin level decrease \>2 g/dL within 48 h of the index endoscopy or direct visualization of active bleeding at the previously treated lesion at repeat endoscopy.
次要结局
- Adverse events potentially related to Hemospray®(From Hemospray application until day +7)
- Mortality(From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first)
研究者
Enrique Rodríguez de Santiago
M.D Gastroenterologist
Hospital Universitario Ramon y Cajal