Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT07249294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective interventional study with single-group assignment. A historical cohort will be used for external comparison but is not part of the randomized arms.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NSAIDs/metamizole prescription', 'timeFrame': '180 days', 'description': 'rate of NSAIDs/metamizole prescriptions in patients with ACLD after surgery'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': '180 days', 'description': 'rate of AKI, ascites, bleeding, and mortality in patients with ACLD after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multidisciplinary', 'Advanced Chronic Liver Disease', 'Surgery', 'NSAIDs', 'Metamizole'], 'conditions': ['Advanced Chronic Liver Disease', 'Portal Hypertension Related to Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '36676081', 'type': 'BACKGROUND', 'citation': 'Canillas L, Pelegrina A, Alvarez J, Colominas-Gonzalez E, Salar A, Aguilera L, Burdio F, Montes A, Grau S, Grande L, Carrion JA. Clinical Guideline on Perioperative Management of Patients with Advanced Chronic Liver Disease. Life (Basel). 2023 Jan 3;13(1):132. doi: 10.3390/life13010132.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to implement measures to avoid the use of NSAIDs or metamizole in patients with advanced chronic liver disease (ACLD) scheduled for major surgery, which are contraindicated due to increased risk of renal dysfunction such as acute kidney injury (AKI), clinical decompensation such as ascites, and bleeding.', 'detailedDescription': 'The "HepatoAINEs" program introduces information and communication technologies (ICTs) to identify patients with ACLD and prevent NSAIDs/metamizole prescription during perioperative care. The intervention includes guideline updates, automated alerts, and multidisciplinary support program (MSP) with collaboration among Digestive, Anesthesia, Surgery, and Pharmacy services to avoid the use of NSAIDs or metamizole in patients with ACLD scheduled for major surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\>18 years) with ACLD scheduled for major surgery\n* Exclusion Criteria: Absence of ACLD or portal hypertension, lack of informed consent'}, 'identificationModule': {'nctId': 'NCT07249294', 'briefTitle': 'Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Multidisciplinary Program to Avoid NSAIDs or Metamizole (HepatoAINEs Study) in Patients With Advanced Chronic Liver Disease Undergoing Major Surgery', 'orgStudyIdInfo': {'id': 'HepatoAINEs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevention Strategy', 'description': 'Participants with cirrhosis will receive an intervention designed to prevent the administration of non-steroidal anti-inflammatory drugs (NSAIDs), which are contraindicated in this population. The intervention includes clinical alerts, prescriber education, and pharmacy verification steps. Outcomes will be compared to a historical cohort of cirrhotic patients who were exposed to NSAIDs prior to implementation of the preventive strategy.', 'interventionNames': ['Behavioral: Multidisciplinary support program']}], 'interventions': [{'name': 'Multidisciplinary support program', 'type': 'BEHAVIORAL', 'description': 'The intervention includes guideline updates, automated alerts, and multidisciplinary support program (MSP) with collaboration among Digestive, Anesthesia, Surgery, and Pharmacy services to avoid the use of NSAIDs or metamizole in patients with cirrhosis.', 'armGroupLabels': ['Prevention Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. MD. PhD.', 'investigatorFullName': 'José Antonio Carrion', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}