Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort
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|ClinicalTrials.gov Identifier: NCT03611504|
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment|
|Gastrointestinal Hemorrhage Ulcer Hemorrhage Tumor Bleeding||Device: Hemospray®|
|Study Type :||Observational|
|Actual Enrollment :||261 participants|
|Official Title:||Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||December 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
Patients with gastrointestinal bleeding treated with Hemospray®.
Other Name: Hemostatic powder
- Hemospray® intraprocedural bleeding control [ Time Frame: 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 [ Time Frame: 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.
- Adverse events potentially related to Hemospray® [ Time Frame: From Hemospray application until day +7 ]Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated.
- Mortality [ Time Frame: From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first ]% of patients who die after Hemospray® application
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611504
|Hospital Universitario Ramón y Cajal|
|Madrid, Spain, 28034|