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Trial registered on ANZCTR


Trial ID
ACTRN12612000573853
Ethics application status
Not yet submitted
Date submitted
16/05/2012
Date registered
28/05/2012
Date last updated
28/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Risk analysis of larger gauge line insertion relating to Peripherally Inserted Central Catheters compared to smaller gauged lines
Scientific title
A comparison of thrombus rates of tapered versus non tapered peripherally inserted central catheters (PICC) in adult patients 18yrs or older able to receive a PICC for intravenous therapy: A review of the thrombus rates in patient groups receiving tapered component versus non tapered component of PICC will be compared.
Secondary ID [1] 280499 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter related thrombus 286476 0
Condition category
Condition code
Blood 286735 286735 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a study review ulilitsing a PICC line with tapper that is larger proximally. Usually the line is inserted and it is decided by the inserter whether to use the larger proximal part of the line or not. This study is going to compare pateints that have had the larger part of the line inserted into the vessels with patients who have not had the tapper inserted. Both patient groups are going to be followed up 7 days post insertion with ultrasound. This study is a pilot comparative study.
Intervention code [1] 284864 0
Not applicable
Comparator / control treatment
Adult patients not receiving reverse tapered device, no tapper will be inserted into this patient population.
Control group
Active

Outcomes
Primary outcome [1] 287131 0
To determine whether utilising reverse taper catheter increase patients risk of thrombosis. The outcome will be assessed using ultrasound to scan the patients and record outcomes
Timepoint [1] 287131 0
7 days post insertion
Secondary outcome [1] 297453 0
To determine whether there is a reduction in catheter migration. Seven days post insertion the catheter will be observed for migration at the follow up ultrasound scan.
Timepoint [1] 297453 0
7 days post insertion

Eligibility
Key inclusion criteria
All randomised controlled trials, and systematic reviews focussing on reverse taper lines and associated thrombus compared to non tapered devices.

All other research designs in the absence of Randomised control trials.

The review will include trials with an adult population receiving both tapered and non tapered devices as a comparator.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Third-party consented patients
patient who have a diagnosis of thrombus
patients who refuse
patients with lymph clearance
Patient with lymphodema
Patents with AV fistulas

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285256 0
Hospital
Name [1] 285256 0
Royal Adelaide Hospital
Address [1] 285256 0
Nursing Director of Critical Care
Royal Adelaide Hospital
North Terrace
Adelaide, SA
5000
Country [1] 285256 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Campus: City East Campus
North Terrace, Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 284118 0
None
Name [1] 284118 0
Address [1] 284118 0
Country [1] 284118 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287273 0
Royal Adelaide Ethics Committee
Ethics committee address [1] 287273 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 287273 0
Date submitted for ethics approval [1] 287273 0
30/06/2012
Approval date [1] 287273 0
Ethics approval number [1] 287273 0

Summary
Brief summary
To review the effects of utilising reverse taper Peripherally Inserted Central Catheters (PICCs), specifically in relation to thrombus formation in deep upper limb vessels.
Trial website
Trial related presentations / publications
2nd World Congress on Vascular Access,
27-29 June 2012 Amsterdam, Beurs van Berlage, The Netherlands
http://www.wocova.com/
Public notes

Contacts
Principal investigator
Name 34183 0
Address 34183 0
Country 34183 0
Phone 34183 0
Fax 34183 0
Email 34183 0
Contact person for public queries
Name 17430 0
Neville Hearse
Address 17430 0
Level 3
Radiology Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 17430 0
Australia
Phone 17430 0
+61 8 8222 4276
Fax 17430 0
Email 17430 0
neville.hearse@health.sa.gov.au
Contact person for scientific queries
Name 8358 0
Adrian Esterman
Address 8358 0
Professor of Biostatistics
Division/Portfolio: Division of Health Sciences
School/Unit: School of Nursing and Midwifery
North Terrace
Adelaide
SA 5000
Country 8358 0
Australia
Phone 8358 0
+61 8 830 22168
Fax 8358 0
Email 8358 0
Adrian.Esterman@unisa.edu.au