The Northern Ireland Haemodialysis Vascular Access Database | NCT04502160

Studies
The Northern Ireland Haemodialysis Vascular Access Database

NCT04502160

Sponsor

Belfast Health and Social Care Trust

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Hemodialysis Access Failure
Arteriovenous Fistula

Interventions

Vascular Access Creation

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2020Actual

Primary Completion Date

Oct 22, 2024Estimated

Completion Date

Oct 22, 2024Estimated

First Submitted Date

Aug 4, 2020

First Submission Date that Met QC Criteria

Aug 4, 2020

First Posted Date

Aug 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2022

Last Update Posted Date

Apr 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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).

AVFs 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.

The aim of this database is to further research in the area of AVF outcomes using routinely collected clinical data..

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vascular Access Creation	Procedure	arteriovenous fistula creation		arteriovenous fistula creation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rates of Arteriovenous Fistula Failure to Mature	Rates of Arteriovenous Fistula Failure to Mature	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital

Exclusion Criteria:

None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

105 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals undergoing AVF creation between January 2009 and December 2020 in a single centre (Belfast City Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agnes Masengu	Contact	0289043819		agnes.masengu@belfasttrust.hscni.net

Overall Officials

Name	Affiliation	Role
Jennifer Hanko	Belfast Health and Social Care Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Belfast City Hospital	Recruiting	Belfast	Antrim	BT9 7AB	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Would require application to Belfast Health and Social Care Trust Research and Development office

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001164	Arteriovenous Fistula

Ancestor Terms

ID	Term
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided