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Completed

NCT Number: NCT03611504

Hemospray in Gastrointestinal Bleeding: 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.

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Key information

Conditions

Gastrointestinal Hemorrhage Digestive System Diseases Gastrointestinal Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Bleeding Ulcer Hemorrhage

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with gastrointestinal bleeding treated with Hemospray®.

Exclusion criteria

  • None.

Treatment and study plan

Hemospray®

Device

Hemospray® application

Other names: Hemostatic powder

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Ramon y Cajal

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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