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| Name | Class |
|---|---|
| University of Salamanca | OTHER |
| Hospital del Mar | OTHER |
| Puerta de Hierro University Hospital | OTHER |
| Complejo Hospitalario de Navarra |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemospray® group | Patients with gastrointestinal bleeding treated with Hemospray®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemospray® | Device | Hemospray® application |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with gastrointestinal bleeding treated with Hemospray®.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
The study database will be available for other researches. The study protocol is already available at AEG-RedCap platform. STROBE guidelines will be followed.
July 2018- December 2019
Accredited researcher or institution. Contact Principal Investigator by email
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| OTHER |
| Hospital de Henares | OTHER |
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
| Quirón Madrid University Hospital | OTHER |
| Hospital de Cruces | OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital Universitario Central de Asturias | OTHER |
| Hospital Universitario de Cabuenes | OTHER |
| Hospital Universitario Doctor Peset | OTHER |
| Hospital del Rio Hortega | OTHER |
| Hospital Universitario Madrid Sanchinarro | OTHER |
| Hospital de Aviles | UNKNOWN |
| Hospital IMQ Zorrozaurre | UNKNOWN |
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% of patients who die after Hemospray® application
| From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first |
| D013568 |
| Pathological Conditions, Signs and Symptoms |