Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort

NCT03611504 | Completed DMC FDA Device

• 1 other identifier: HRC-HEMOSPRAY
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Hemorrhage; Ulcer Hemorrhage; Tumor Bleeding

Keywords

Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse events potentially related to Hemospray®

  From Hemospray application until day +7

• Mortality

  From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first

Study Arms (1)

Hemospray® group

Patients with gastrointestinal bleeding treated with Hemospray®.

Device: Hemospray®

Interventions

Hemospray® DEVICE

Hemospray® application

Also known as: Hemostatic powder

Hemospray® group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gastrointestinal bleeding treated with Hemospray®.

You may qualify if:

• Patients with gastrointestinal bleeding treated with Hemospray®.

You may not qualify if:

• None.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D Gastroenterologist

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 2, 2018
• Study Start: July 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: July 2018- December 2019
• Access Criteria: Accredited researcher or institution. Contact Principal Investigator by email

Locations

ES (1)