Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000387426
Ethics application status
Approved
Date submitted
21/03/2016
Date registered
24/03/2016
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Central Venous Access Device (CVAD) Registry - an electronic database to monitor the outcomes of patients with CVADs
Scientific title
Central Venous Access Device (CVAD) Registry - an electronic database to monitor the outcomes of patients with CVADs.
Secondary ID [1] 288776 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CVAD failure (infective and mechanical complications) 298039 0
Condition category
Condition code
Infection 298243 298243 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
The CVAD Registry is designed to capture information relevant to CVAD insertion, management and outcomes for patients receiving in-patient and out-patient treatment. The Registry will collate data that is currently collected within multiple departments and store it in a single database. It will enable researchers and clinicians to explore CVAD trends and examine device-related complications, as well as increase their understanding of device failure, therefore improving clinical outcomes for patients with CVADs.
The CVAD Registry will prospectively collect clinical data on CVAD characteristics, adverse outcomes and risk factors. Clinical data will be collected on all patients requiring a CVAD.on or after the Registry commencement date at participating sites. Patient outcomes will be monitored through electronic medical records until the final CVAD is removed or the patient dies.
Intervention code [1] 294222 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297706 0
To measure the CVAD outcomes (annual CVAD failure rate per 1000-CVAD-days; annual CVAD failure rate per 1000-patient-days) for patients receiving treatment at participating sites. This will be assessed by reviewing electronic medical records and recording the number of days each patient has a CVAD; the number of days each patient is in hospital with a CVAD and recording the outcome (device still in place; reason for device removal) for each CVAD the patient receives at participating sites.
Timepoint [1] 297706 0
At the time of CVAD removal or after the patient has deceased. Initial findings of CVAD Registry will be analysed after twelve months of data collection.
Secondary outcome [1] 321926 0
To identify the cause of CVAD failure per patient and rate of each CVAD Failure subtype within patient population. CVAD failure will be classified into the following subtypes - catheter occlusion; catheter-related thrombosis; migration; dislodgement; CVAD rupture; catheter-related bloodstream infection (CRBSI); central line associated bloodstream infection (CLABSI); catheter-related infection (CRI). This outcome will be assessed by reviewing electronic medical records and pathology records.
Timepoint [1] 321926 0
At the time of CVAD removal or after the patient has deceased. Initial findings of CVAD Registry will be analysed after twelve months of data collection.
Secondary outcome [2] 321927 0
To measure characteristics about patient population with CVADs at participating sites (e.g. CVAD utilisation ratio; dwell time; number of CVADs required to complete treatment; number of CVAD days; number of in-patient days; patient demographics). This outcome will be assessed by reviewing electronic medical records.
Timepoint [2] 321927 0
At the time of final CVAD removal or after patient has deceased. Initial findings of CVAD Registry will be analysed after twelve months of data collection.

Eligibility
Key inclusion criteria
For RBWH site: All patients who have a CVAD inserted at the RBWH on or after the Registry commencement date.

For TPCH site: All patients who had a CVAD inserted at the TPCH on or after 1st April 2016.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria for the Registry.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Approximately 900 CVADs are inserted into patients receiving cancer care services (CCS) at RBWH per annum. To date, there is no data source available that records the number of CVADs inserted across the participating sites. No sample size calculation was required, as the entire cohort of eligible patients who have a CVAD inserted at the participating sites during the pilot registry period will be included, Continuous data will be presented with medians, interquartile ranges or means and standard deviations, as appropriate and categorical data as rates and percentages. CVAD failure will be calculated by dividing CVAD failure (infective or mechanical) in patients with a CVAD by the number of CVAD days and multiplying by 1000. Survival analysis will be used to evaluate time-to-event data (e.g. time to catheter failure). Additionally, clinicians and researchers interested in CVADs and CVAD failure will be able to request permission to access de-identified data held on CVAD Registry if they have successfully gained ethical approval.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2016
Actual
1/04/2016
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
2000
Accrual to date
860
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5477 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 10692 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 12940 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 22414 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 293144 0
Hospital
Name [1] 293144 0
Metro North Hospital and Health Service (MNHHS)
Country [1] 293144 0
Australia
Primary sponsor type
Individual
Name
Nicole Gavin
Address
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 291938 0
Individual
Name [1] 291938 0
Sarah Northfield
Address [1] 291938 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country [1] 291938 0
Australia
Secondary sponsor category [2] 298502 0
Individual
Name [2] 298502 0
Rebecca Lippiatt
Address [2] 298502 0
Cancer Care Services, Royal Brisbane and Women's Hospital, Building 34, Level 2 Butterfield St Herston QLD 4029
Country [2] 298502 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294663 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 294663 0
Human Research Ethics Office
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield St
Herston
Queensland 4029
Ethics committee country [1] 294663 0
Australia
Date submitted for ethics approval [1] 294663 0
17/12/2015
Approval date [1] 294663 0
20/01/2016
Ethics approval number [1] 294663 0
HREC/15/QRBW/643

Summary
Brief summary
Treatment today is unthinkable without vascular access devices for the management of patients. CVADs are essential for the administration of intravenous medications and blood sampling. This registry will collect information about the patients requiring CVADs, the type of CVADs being inserted, any complications experienced and the reasons for removal. The registry will provide clinicians and researchers with first-hand information about CVADs for patients receiving treatment and over time will increase our understanding of the complications associated with CVADs. The CVAD Registry will provide clinicians and researchers with an increased understanding of device failure, therefore improving clinical outcomes for patients with CVADs. The CVAD Registry will prospectively collect clinical data on device characteristics, adverse outcomes and risk factors. The Registry will:
1. Store existing clinical data pertaining to patients with CVADs in one database.
2. Facilitate quality improvement and research projects about patients with CVADs.
Trial website
Trial related presentations / publications
Public notes
The pilot CVAD Registry will first be implemented in Cancer Care Services stream of the Royal Brisbane and Women's Hospital and in Critical Care Services stream of The Prince Charles Hospital. The CVAD Registry will slowly be rolled out to other sites, after initial feasibility assessments have been completed.

Contacts
Principal investigator
Name 64446 0
Mrs Nicole Gavin
Address 64446 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country 64446 0
Australia
Phone 64446 0
+61 7 36465833
Fax 64446 0
N/A
Email 64446 0
[email protected]
Contact person for public queries
Name 64447 0
Miss Sarah Northfield
Address 64447 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country 64447 0
Australia
Phone 64447 0
+61 7 36462182
Fax 64447 0
N/A
Email 64447 0
[email protected]
Contact person for scientific queries
Name 64448 0
Mrs Nicole Gavin
Address 64448 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country 64448 0
Australia
Phone 64448 0
+61 7 36465833
Fax 64448 0
N/A
Email 64448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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