An observational study in Gastrointestinal Hemorrhage, Ulcer Hemorrhage and Tumor Bleeding, sponsored by Hospital Universitario Ramon y Cajal. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Hospital Universitario Ramon y Cajal · Observational
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 261 is above the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Hospital Universitario Ramon y Cajal is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with gastrointestinal bleeding treated with Hemospray®.
Exclusion Criteria:
Patients with gastrointestinal bleeding treated with Hemospray®.
Device: Hemospray®
Hemospray® application
Also known as: Hemostatic powder
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
Plan to share: Yes — The study database will be available for other researches. The study protocol is already available at AEG-RedCap platform. STROBE guidelines will be followed.
Supporting information: Study protocol, Sap, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Ramon y Cajal