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.
Study Type
OBSERVATIONAL
Enrollment
261
Hemospray® application
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hemospray® intraprocedural bleeding control
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.
Time frame: From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.
Rebleeding rate
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.
Time frame: Date of Hemospray® application until rebleeding, assessed up to 48 months
Adverse events potentially related to Hemospray®
Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated.
Time frame: From Hemospray application until day +7
Mortality
% of patients who die after Hemospray® application
Time frame: From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first
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