Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort

Completed

• Conditions: Tumor Bleeding; Gastrointestinal Hemorrhage; Ulcer Hemorrhage
• Interventions: Device: Hemospray®

• Registration Number: NCT03611504
• Lead Sponsor: Hospital Universitario Ramon y Cajal

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• Patients with gastrointestinal bleeding treated with Hemospray®.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemospray® group	Hemospray®	Patients with gastrointestinal bleeding treated with Hemospray®.

Primary Outcome Measures

Name	Time	Method
Hemospray® intraprocedural bleeding control	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	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events potentially related to Hemospray®	From Hemospray application until day +7	Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated.
Mortality	From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first	% of patients who die after Hemospray® application

Trial Locations

Locations (1)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain