Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort

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

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 Overview

• Status: Completed
• Conditions: Gastrointestinal Hemorrhage; Ulcer Hemorrhage; Tumor Bleeding
• Intervention / Treatment: Device: Hemospray®

• Study Type: Observational
• Enrollment (Actual): 261

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with gastrointestinal bleeding treated with Hemospray®.

Description

Inclusion Criteria:

• Patients with gastrointestinal bleeding treated with Hemospray®.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemospray® group; Patients with gastrointestinal bleeding treated with Hemospray®.	Device: Hemospray®; Hemospray® application; Other Names: Hemostatic powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Collaborators: Hospital General Universitario Gregorio Marañon; Complejo Hospitalario de Navarra; Hospital del Mar; Puerta de Hierro University Hospital; University of Salamanca; Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Hospital del Rio Hortega; Hospital Universitario Central de Asturias; Hospital Universitario Doctor Peset; Hospital de Henares; Quirón Madrid University Hospital; Hospital de Cruces; Hospital Universitario de Cabuenes; Hospital Universitario Madrid Sanchinarro; Hospital de Aviles; Hospital IMQ Zorrozaurre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: HRC-HEMOSPRAY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study database will be available for other researches. The study protocol is already available at AEG-RedCap platform. STROBE guidelines will be followed.
• IPD Sharing Time Frame: July 2018- December 2019
• IPD Sharing Access Criteria: Accredited researcher or institution. Contact Principal Investigator by email
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No