Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort

Gastrointestinal Hemorrhage Clinical Trial

Official title:

Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611504
• Other study ID #: HRC-HEMOSPRAY
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2019
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with gastrointestinal bleeding treated with Hemospray®.

Exclusion Criteria:

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Tumor Bleeding
• Ulcer Hemorrhage

Intervention

Device:
• Hemospray®
Hemospray® application

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (17)

Lead Sponsor

Collaborator

Hospital Universitario Ramon y Cajal

Complejo Hospitalario de Navarra, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital de Aviles, Hospital de Cruces, Hospital de Henares, Hospital del Mar, Hospital del Río Hortega, Hospital General Universitario Gregorio Marañon, Hospital IMQ Zorrozaurre, Hospital Universitario Central de Asturias, Hospital Universitario de Cabueñes, Gijón, Spain, Hospital Universitario Doctor Peset, Hospital Universitario Madrid Sanchinarro, Puerta de Hierro University Hospital, Quirón Madrid University Hospital, University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.
Primary	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.	Date of Hemospray® application until rebleeding, assessed up to 48 months
Secondary	Adverse events potentially related to Hemospray®	Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated.	From Hemospray application until day +7
Secondary	Mortality	% of patients who die after Hemospray® application	From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first