Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-25 @ 9:25 PM
Study NCT ID:
NCT03611504
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemospray® intraprocedural bleeding control', 'timeFrame': 'From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.', 'description': '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.'}, {'measure': 'Rebleeding rate', 'timeFrame': 'Date of Hemospray® application until rebleeding, assessed up to 48 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Adverse events potentially related to Hemospray®', 'timeFrame': 'From Hemospray application until day +7', 'description': 'Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated.'}, {'measure': 'Mortality', 'timeFrame': 'From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first', 'description': '% of patients who die after Hemospray® application'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder'], 'conditions': ['Gastrointestinal Hemorrhage', 'Ulcer Hemorrhage', 'Tumor Bleeding']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gastrointestinal bleeding treated with Hemospray®.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with gastrointestinal bleeding treated with Hemospray®.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT03611504', 'briefTitle': 'Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.', 'orgStudyIdInfo': {'id': 'HRC-HEMOSPRAY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemospray® group', 'description': 'Patients with gastrointestinal bleeding treated with Hemospray®.', 'interventionNames': ['Device: Hemospray®']}], 'interventions': [{'name': 'Hemospray®', 'type': 'DEVICE', 'otherNames': ['Hemostatic powder'], 'description': 'Hemospray® application', 'armGroupLabels': ['Hemospray® group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'July 2018- December 2019', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'Accredited researcher or institution. Contact Principal Investigator by email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Salamanca', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario de Navarra', 'class': 'OTHER'}, {'name': 'Hospital de Henares', 'class': 'OTHER'}, {'name': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa', 'class': 'OTHER'}, {'name': 'Quirón Madrid University Hospital', 'class': 'OTHER'}, {'name': 'Hospital de Cruces', 'class': 'OTHER'}, {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, {'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}, {'name': 'Hospital Universitario de Cabuenes', 'class': 'OTHER'}, {'name': 'Hospital Universitario Doctor Peset', 'class': 'OTHER'}, {'name': 'Hospital del Rio Hortega', 'class': 'OTHER'}, {'name': 'Hospital Universitario Madrid Sanchinarro', 'class': 'OTHER'}, {'name': 'Hospital de Aviles', 'class': 'UNKNOWN'}, {'name': 'Hospital IMQ Zorrozaurre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D Gastroenterologist', 'investigatorFullName': 'Enrique Rodríguez de Santiago', 'investigatorAffiliation': 'Hospital Universitario Ramon y Cajal'}}}}