Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT04502160
Status:
UNKNOWN
Last Update Posted:
2022-04-21
First Post:
2020-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Northern Ireland Haemodialysis Vascular Access Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-10-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2020-08-04', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Arteriovenous Fistula Failure to Mature', 'timeFrame': '1 year', 'description': 'Rates of Arteriovenous Fistula Failure to Mature'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis Access Failure', 'Arteriovenous Fistula']}, 'descriptionModule': {'briefSummary': 'This is database designed to explore clinical outcomes related to vascular assess in the population of Northern Ireland with CKD Stage 5 and End-stage Renal Failure.', 'detailedDescription': 'Vascular access is the conduit by which blood is transferred from the patient to the dialysis machine and back to the patient during therapy. There are three types of vascular access: Arteriovenous fistulas (AVF), Central venous catheters (CVC) and Arteriovenous grafts (AVG).\n\nAVFs are associated with the best patient survival in individuals undergoing dialysis therapy. However, Up 30-50% of AVFs thrombose or fail to mature sufficiently to support dialysis.\n\nThe aim of this database is to further research in the area of AVF outcomes using routinely collected clinical data..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals undergoing AVF creation between January 2009 and December 2020 in a single centre (Belfast City Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04502160', 'acronym': 'NIVAD', 'briefTitle': 'The Northern Ireland Haemodialysis Vascular Access Database', 'organization': {'class': 'OTHER', 'fullName': 'Belfast Health and Social Care Trust'}, 'officialTitle': 'The Northern Ireland Haemodialysis Vascular Access Database', 'orgStudyIdInfo': {'id': '19089JH-SS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vascular Access Creation', 'type': 'PROCEDURE', 'otherNames': ['arteriovenous fistula creation'], 'description': 'arteriovenous fistula creation'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Antrim', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Agnes Masengu', 'role': 'CONTACT', 'email': 'agnes.masengu@belfasttrust.hscni.net'}, {'name': 'Jennifer Hanko', 'role': 'CONTACT', 'email': 'jennifer.hanko@belfasttrust.hscni.net'}, {'name': 'Agnes Masengu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer Hanko', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'centralContacts': [{'name': 'Agnes Masengu', 'role': 'CONTACT', 'email': 'agnes.masengu@belfasttrust.hscni.net', 'phone': '0289043819'}], 'overallOfficials': [{'name': 'Jennifer Hanko', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Belfast Health and Social Care Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Would require application to Belfast Health and Social Care Trust Research and Development office'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belfast Health and Social Care Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}