Gastrointestinal Hemorrhage, Tumor Bleeding, Ulcer Hemorrhage
Conditions
Keywords
Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder
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.
Interventions
DEVICEHemospray®
Hemospray® application
Sponsors
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 Cabuenes
Hospital Universitario Doctor Peset
Hospital del Rio Hortega
Hospital Universitario Madrid Sanchinarro
Hospital de Aviles
Hospital IMQ Zorrozaurre
Hospital Universitario Ramon y Cajal
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with gastrointestinal bleeding treated with Hemospray®.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemospray® intraprocedural bleeding control | 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. |
| Rebleeding rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events potentially related to Hemospray® | From Hemospray application until day +7 | Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated. |
| Mortality | From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first | % of patients who die after Hemospray® application |
Countries
Spain
Outcome results
None listed