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Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort

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ClinicalTrials.gov Identifier: NCT03611504
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
University of Salamanca
Hospital del Mar
Puerta de Hierro University Hospital
Complejo Hospitalario de Navarra
Hospital de Henares
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Quirón Madrid University Hospital
Hospital de Cruces
Hospital General Universitario Gregorio Marañon
Hospital Universitario Central de Asturias
Hospital Universitario de Cabueñes, Gijón, Spain
Hospital Universitario Doctor Peset
Hospital del Río Hortega
Hospital Universitario Madrid Sanchinarro
Hospital de Aviles
Hospital IMQ Zorrozaurre
Information provided by (Responsible Party):
Enrique Rodríguez de Santiago, 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.

Condition or disease Intervention/treatment
Gastrointestinal Hemorrhage Ulcer Hemorrhage Tumor Bleeding Device: Hemospray®

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Study Type : Observational
Actual Enrollment : 261 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hemospray® group
Patients with gastrointestinal bleeding treated with Hemospray®.
Device: Hemospray®
Hemospray® application
Other Name: Hemostatic powder




Primary Outcome Measures :
  1. Hemospray® intraprocedural bleeding control [ Time Frame: 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.

  2. Rebleeding rate [ Time Frame: 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 :
  1. Adverse events potentially related to Hemospray® [ Time Frame: From Hemospray application until day +7 ]
    Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated.

  2. Mortality [ Time Frame: From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first ]
    % of patients who die after Hemospray® application



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with gastrointestinal bleeding treated with Hemospray®.
Criteria

Inclusion Criteria:

  • Patients with gastrointestinal bleeding treated with Hemospray®.

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611504


Locations
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Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
University of Salamanca
Hospital del Mar
Puerta de Hierro University Hospital
Complejo Hospitalario de Navarra
Hospital de Henares
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Quirón Madrid University Hospital
Hospital de Cruces
Hospital General Universitario Gregorio Marañon
Hospital Universitario Central de Asturias
Hospital Universitario de Cabueñes, Gijón, Spain
Hospital Universitario Doctor Peset
Hospital del Río Hortega
Hospital Universitario Madrid Sanchinarro
Hospital de Aviles
Hospital IMQ Zorrozaurre

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Responsible Party: Enrique Rodríguez de Santiago, M.D Gastroenterologist, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT03611504     History of Changes
Other Study ID Numbers: HRC-HEMOSPRAY
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: July 2018- December 2019
Access Criteria: Accredited researcher or institution. Contact Principal Investigator by email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Enrique Rodríguez de Santiago, Hospital Universitario Ramon y Cajal:
Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder

Additional relevant MeSH terms:
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Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemostatics
Coagulants